THE ANNUAL MEETING NEWS DAILY
Inside
5 6
Visit AAN.com Booth to Join the Conversation with Popular Synapse Online Communities New “Best of” Scientific Platform Sessions Provide Perfect Lead-in to Daily Plenary Sessions
Session III Opens 13 Poster This Morning at 8:30,
Posters Grouped by Topic “Neighborhoods”
a Presidential View 14 Get of How Neurology Has
Tuesday, April 25, 2017
Significant Clinical Trials to Be Covered in This Morning’s Clinical Trials Plenary Session Experts will present important clinical topics that affect patient care during this morning’s Clinical Trials Plenary Session. Attendees can expect to learn about the latest updates within several clinical trials conducted over the course of the last year. Effect of Intensive Systolic Blood Pressure Lowering on Hematoma Expansion in Patients with Intracerebral Hemorrhage: Analysis of Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH) II Trial Joshua N. Goldstein, MD, PhD Massachusetts General Hospital, Boston, MA
Evolved
Joshua N. Goldstein, MD, PhD
Continued on page 21 u
Get Up-to-date on Zika Virus at Today’s Neuroscience in the Clinic Session Hear from experts about Zika virus and other neurotropic viruses at today’s Neuroscience in the Clinic Session, which features a mix of scientists and clinicians engaged in lively case discussions to integrate scientific research with clinical application. Cynthia L. Harden, MD, and Elizabeth Donner, MD, FRCPC, at press conference
New SUDEP Guideline Reviewed at Press Conference The AAN held a press conference yesterday in the Boston Convention & Exhibition Center in connection with the publication of its new “Practice Guideline: Sudden Unexpected Death in Epilepsy Incidence Rates and Risk Factors.” The guideline was published online in Neurology ® on Monday, April 24, and in print in Neurology on April 25. The guideline was co-developed with the American Epilepsy Society and endorsed by the International Child Neurology Association. Continued on page 13 u
Neuroscience in the Clinic: Zika Virus: The Global Outbreak of a Neurotropic Virus 1:00 p.m.–3:00 p.m. Coordinators: Allen J. Aksamit, Jr., MD, FAAN; Kiran Thakur, MD
This program will provide updates on recent outbreaks of Zika and other neurologic infections, and the overlap between neurological infections and autoimmune manifestations. The last decade has seen the emergence and re-emergence of several neurotropic infections, including Zika virus, Continued on page 7 u
Tuesday, April 25, 2017 • AANextra
1
HARNESSING SCIENCE
to improve lives
At MT Pharma America, we understand that people with debilitating neurological diseases are determined to live life on their own terms. This is especially true for people living with amyotrophic lateral sclerosis, or ALS, our current focus. That is why we have paired a global expertise in research and development with veterans in the US life sciences industry. We are working together with advocacy organizations to expand disease education and elevate awareness that may lead to improvements in diagnosis, treatment, and discovery.
Discover our current efforts at Booth 721
and mt-pharma-america.com
Inspired by patients. Grounded in science.
Š 2017 MT Pharma America, Inc. All rights reserved. CP-MTPA-US-0002 04/17
Tuesday, April 25 1 1 1 5 6 7 9
New SUDEP Guideline Reviewed at Press Conference Significant Clinical Trials to Be Covered in This Morning’s Clinical Trials Plenary Session Get Up-to-date on Zika Virus at Today’s Neuroscience in the Clinic Session Visit AAN.com Booth to Join the Conversation with Popular Synapse Online Communities New “Best of” Scientific Platform Sessions Provide Perfect Lead-in to Daily Plenary Sessions Daily Reminders Delve into Neuro-oncology This Afternoon with Invited Science Session
10 Today’s Experiential Learning Area
The Vision of the AAN is to be indispensable to our members.
13 Poster Session III Opens This
The Mission of the AAN is to promote the highest quality patient-centered neurologic care and enhance member career satisfaction.
14 Get a Presidential View of How
Contact Information:
Highlights
Morning at 8:30, Posters Grouped by Topic “Neighborhoods” Neurology Has Evolved
American Academy of Neurology 201 Chicago Avenue Minneapolis, MN 55415 USA
20 Tweets of the Day 23 Palatucci Forum Leads to Fulfillment
(800) 879-1960 (Toll Free) or (612) 928-6100 (International) (612) 454-2744 memberservices@aan.com AAN.com
Phone:
of Member’s Dreams for Patients
Fax: Email: Website:
25 AAN and WFN Leaders Meet 28 What Are People Saying? 30 Improve Your Patients’ Experience
AAN Executive Director/CEO:
Catherine M. Rydell, CAE
Managing Editor: Angela Babb, CAE
with Interactive Electronic Exam Room Posters
Editor: Tim Streeter Writers: Ryan Knoke, Sarah Parsons
30 New to the Annual Meeting?
Designer: Jim Hopwood
Tomorrow’s Orientation Session Is for You!
Photography: Siu Lee Printing: Universal Wilde, Inc. Email: aannews@aan.com AANextra is published by the American Academy of Neurology.
Boxed Lunch Menu Tuesday, April 25
The American Academy of Neurology’s registered trademarks and service marks are registered in the United States and various other countries around the world. “American Brain Foundation” is a registered service mark of the American Brain Foundation and is registered in the United States.
Smoking Gobbler Smoked turkey, cranberry chutney, sage aioli, and sharp Vermont cheddar on whole wheat bulkie roll Cherry Wood Smoked Salmon Caesar Salad (GF) Tuscan kale, traditional dressing, GF croutons, and shaved parmesan Quinoa and Roasted Root Vegetable Salad Tahini dressing (V, GF) Each lunch includes: wild rice and diced salad – dried fruit, roasted peppers, and maple vinaigrette, Granny Smith apple, whoopie pie
, AprIL TUESDAY
THE ANNUAL
MEETING
NEWS
5
V–vegan · GF–gluten free
25, 2017
red in s to Be Cove Session Clinical Trial s Plenary Significantning’s Clinical Trial This Mor
DAILY
Inside
to om Booth Visit AAN.c rsation with Conve Join the se Online r Synap Popula unities Comm ific of” Scient e Provid New “Best Sessions y Platform to Dail Lead-in Perfect Sessions Plenary III Opens Session Poster ng at 8:30,Topic by This Morni Grouped Posters ods” “Neighborho ential View Get a Presid logy Has Neuro of How Evolved
6
13
nt clinical
importa during this care . will present patient Session Experts that affect Trials Plenary about the topics to learn g’s Clinical trials mornin expect clinical es can several last year. Attende within of the the course latest updates ted over Blood conduc e Systolic oma of Intensivng on Hemat Effect re Loweri s with Pressu ion in Patient rhage: Expans Hemor ve rebral Intrace of Antihypertensi l s Cerebra Analysi Acute II Trial ent of ) Treatm (ATACH PhD rhage in, MD, l, Hemor l Hospita N. Goldste Genera Joshua husetts Massac , MA Boston
, MD, PhD N. Goldstein
ed on page Continu
u 21
Virus at te on Zika in the Clinic Get Up-to-da roscience Today’s Neu Session Joshua
14
opic viruses other neurotr virus and , which about Zika Clinic Session experts in the s Hear from Neuroscience ts and clinician at today’s mix of scientis ions to discuss clinical sa feature in lively case h with d engage scientific researc e integrat ion. applicat Clinic:
MD, FRCPC,
at press
e conferenc
Reviewed EP Guideline New SUD Conference at Press and Elizabeth
Donner,
in the cience Outbreak Neuros The Global Zika Virus: ropic Virus of a Neurot
MD, it, Jr., 00 p.m. Aksam 1:00 p.m.–3: Allen J. MD ators: Coordin Kiran Thakur, on gic updates MD, FAAN; has will provideand other neurolo gical This program ks of Zika between neurolo The last decadeopic Boston tion outbrea ay in the neurotr publica recent the overlap manifestations. of several nce yesterd tion with the une ns, and in u 7 infectio and autoimm re-emergence press confere in connec cted Death ed on page ns held a Center Unexpe guideline was Continu infectio emergence and virus, The AAN & Exhibition e: Sudden in print .” The tion seen the including Zika extra Factors April 24, and Conven “Practice Guidelin • AAN ns, with y, and Risk 2017 infectio April 25, of its newIncidence Rates gy ® on Monda co-developed ional Tuesday, y e was Internat the Epileps online in Neurolo by guidelin d The u ed 13 and endorse publish gy on April 25. ed on page Society Continu in Neurolo an Epilepsy tion. the Americ gy Associa Neurolo Child Cynthia
Today’s AAN Section Meetings Tuesday, April 25—Westin Galleria 7:00 a.m.–8:00 a.m.
Ethics Section General Neurology Section Neuro-Infectious Disease Section 12:00 p.m.–1:00 p.m.
Endovascular & Interventional Neurology Section Headache & Facial Pain Section
4
Tuesday, April 25, 2017 • AANextra
Neuroimaging Section Women’s Issues in Neurology Section 5:30 p.m.–6:30 p.m.
Behavioral Neurology Section Global Health Section Multiple Sclerosis Section Sleep Medicine Section
L. Harden,
1
The American Academy of Neurology sincerely thanks Universal Wilde, Inc. for its exceptional service, steadfast professionalism, and high-quality standards, as well as its generous donation of the 2017 Brain Health Fair program guide.
Visit AAN.com Booth to Join the Conversation with Popular Synapse Online Communities In early 2016, the AAN launched SynapseSM Online Communities, the official communication platform for all AAN Sections. Positioned to be the global conversation for all things neurology, Synapse offers a new opportunity for members within similar areas of interest to exchange ideas for advancing neuroscience and strengthening patient care, share insights on the latest news in the world of neurology, and gain and offer perspectives and solutions for all facets and career levels of the field. Since its debut, this AAN member-only benefit has grown to 37 public communities—recently adding Autoimmune Neurology, Business Administration, Neurohealth & Integrative Neurology, and LGBTQI—serving more than 9,000 member neurologists and neuroscience professionals, residents and fellows, researchers, and businesses administrators from around the world. This engagement reflects an increase of more than 700 additional section members over the past year.
Visit the AAN.com booth outside Meeting Administration in the North Lobby of the convention center this week to learn more about and see a demonstration of Synapse—or to get signed up so you can join the conversation, too! Learn more at AAN.com/synapse.
Through Synapse, AAN members have been able to: Exchange insights on professional-related topics and issues Share expertise, find answers to tough questions, and strengthen the care they provide Discuss timely news and science affecting the field of neurology Offer real-world solutions to practice, patient care, academia, and other areas of the neurology profession—across all career levels Quickly and easily provide feedback on section-relevant AAN programs and services Download and share documents and images through the Synapse digital library
MEM: 16 Live Well Ads Ad—Half horizontal Page> AANextra Placed in AANextra 8.25 x 4.4375 +0.125 bleed, 4C
Live Well Taking Care of Your Patients Starts with Taking Care of You
Neurologists have one of the highest rates of burnout and lowest rates of work-life balance among medical specialties. Find practical solutions to revitalize your well-being.
AAN.com/LiveWell
New “Best of” Scientific Platform Sessions Provide Perfect Lead-in to Daily Plenary Sessions You won’t want to miss these daily platform sessions that bring together the top four scoring abstracts in a particular topic, as rated by the topic reviewers. These new and unique sessions offer an opportunity to discuss findings directly with the authors in a smaller, more intimate setting, and conclude with a 15-minute “meet the investigators.” This is your chance to interact one-on-one with presenters to have your questions answered!
Tuesday, April 25
Thursday, April 27
Friday, April 28
Cerebrovascular Disease and Interventional Neurology 8:00 a.m.–9:00 a.m. Room: 205ABC Precedes Clinical Trials Plenary Session beginning at 9:15 a.m
Epilepsy 8:00 a.m.–9:00 a.m. Room: 205ABC Precedes Controversies in Neurology Plenary Session beginning at 9:15 a.m.
Aging and Dementia 8:00 a.m.–9:00 a.m. Room: 205ABC Precedes Neurology Year in Review Plenary Session beginning at 9:15 a.m.
Topics include: In Vivo Two-photon Calcium Imaging of Excitatory Pyramidal Neurons and Inhibitory Fast-spiking Parvalbuminpositive Interneurons During Temperature-induced Seizures in a Mouse Model of Dravet Syndrome Seizure Triggers in Epilepsy Patients: A National Perspective The Importance of Family Planning as a Determinant of Spontaneous Fetal Loss in Women with Epilepsy: Findings of the Epilepsy Birth Control Registry Extrapolation of Efficacy Data from Adults with Primary Generalized Tonicclonic Seizures (PGTC) to Pediatric Patients: A Meta-analysis of Published Clinical Trials
Topics include: Ante Mortem CSF Tau Levels Correlate with Post Mortem Tau Pathology in FTLD The Advancing Research and Treatment in Frontotemporal Lobar Degeneration (ARTFL) North American Rare Disease Clinical Research Consortium: Progress and Characterization of Initial Participants Blood Pressure Trajectories from Mid to Late Life and Risk of Dementia: The Framingham Study Sleep Apnea During NREM But Not REM Inversely Correlates with CSF Amyloid Beta 42 But Not Tau Levels
Topics include: Fully Automated Pipeline for White Matter Hyperintensity Segmentation Using Clinical Scans in Patients with Acute Ischemic Stroke Recanalization Therapy Is Associated with Lower Odds of 30-Day Readmission: An Analysis of the Nationwide Readmission Database Disparities in Delivery of Endovascular Therapy: The Florida Puerto Rico Collaboration to Reduce Stroke Disparities Study (CReSD) Time-course of Functional Recovery After Acute Ischaemic Stroke and its Relationship to Cause-specific mortality: Implications for Follow-up of Stroke Trials
Wednesday, April 26 Neuromuscular Disease Therapeutics 8:00 a.m.–9:00 a.m. Room: 205ABC Precedes Frontiers in Neuroscience Plenary Session beginning at 9:15 a.m. Topics include: Rasagiline for the Treatment of ALS: A Randomized Controlled Study Oral Fingolimod in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (FORCIDP): Results from a Phase III Randomized Placebo-controlled Trial AVXS-101 Phase 1 Gene Therapy Clinical Trial in SMA Type 1: Event Free Survival and Achievement of Developmental Milestones Phase 2 Open-Label Extension (OLE) Study of Patisiran, an Investigational RNA interference (RNAi) Therapeutic for the Treatment of Hereditary ATTR Amyloidosis with Polyneuropathy
6
Tuesday, April 25, 2017 • AANextra
For additional session information, including full listing of presenters, refer to the Annual Meeting App.
Get Up-to-date on Zika Virus at Today’s Neuroscience in the Clinic Session continued from cover
Chikungunya virus, and drug resistant tuberculous meningitis. Infections which were once thought to be limited to tropical and subtropical regions are now having global impact, the most recent and expansive being Zika virus. The clinical manifestations and socioeconomic impact of Zika virus and other neurological infections is often devastating, particularly in resource-limited settings. 1:00 p.m.–1:05 p.m. Introduction — Omar Siddiqi, MD 1:05 p.m.–1:15 p.m. Zika Case Presentation—Adult Manifestation —Kiran Thakur, MD 1:15 p.m.–1:45 p.m. Epidemiological Update —James J. Sejvar, MD 1:45 p.m.–2:15 p.m. Neurovirology and Neuropathogenesis — Carlos A. Pardo-Villamizar, MD 2:15 p.m.–2:20 p.m. Introduction of Science Presentations — Allen J. Aksamit, Jr., MD, FAAN; Arun Venkatesan, MD, PhD 2:20 p.m.–2:30 p.m. N4.001: Expanding Spectrum of Neurologic Manifestations with Zika Virus Infection —Laura S. Surillo Dahdah, MD 2:30 p.m.–2:40 p.m. N4.002: Neuroviruses Emerging in the Americas Study (NEAS): The Colombian Experience During the 2016 Outbreak of Zika Virus Infection —Laura S. Munoz 2:40 p.m.–3:00 p.m. Panel Discussion
Daily Reminders Education Program Syllabi and Slides Available Online Only Education Program syllabi and slides are available online only at AAN.com/view/syllabi or through the Annual Meeting Mobile App at AAN.com/view/app.
May 8 Is Deadline to Submit Online Evaluations for Annual Meeting CME Complete your evaluations to get your CME hours by using the Annual Meeting Mobile App at AAN.com/view/app or by visiting AAN.com/view/CME. CME requests may be made until May 8, 2017.
Save 10 Percent Shopping Online at The AAN Store®! This year, Annual Meeting attendees can receivet 10 percent off online orders placed by April 28 at AAN.com/AANStore. Go online, shop, and use Promo Code AM10 at checkout for your Annual Meeting discount.
In MS what is the impact of the neurodegeneration we don't see?
Join us at Booth 771 to explore the foundations of neurodegeneration in MS
Š 2017 Teva Neuroscience, Inc. NEUR-40937 February 2017
Delve into Neuro-oncology This Afternoon with Invited Science Session Top abstracts previously presented at the Society for Neuro-oncology Annual Meeting will be presented by their authors in 20-minute platform presentations today from 1:00 p.m. to 3:00 p.m. Select abstracts from their “best of” lineups emphasize basic, clinical, and translational science as they evolve toward a more complete understanding of headache with the overall goal of developing more effective prevention and treatment. 1:00 p.m.–1:20 p.m. ACT IV: An International, Double-blind, Phase 3 Trial of Rindopepimut in Newly Diagnosed, EGFRvIII-expressing Glioblastoma Michael Weller, MD, Zurich, Switzerland 1:20 p.m.–1:40 p.m. Targeting Carcinoma–astrocyte Gap Junctions in Brain Metastasis Mariza Daras, MD, New York, NY 1:40 p.m.–2:00 p.m. Single-cell Profiling of Glioblastoma Biopsies Identifies a Family of Activating PDGF-receptor Deletions Soeren Mueller, PhD, San Francisco, CA
2:20 p.m.–2:40 p.m. Phase 2 Study to Evaluate the Clinical Efficacy and Safety of MEDI4736 (Durvalumab [DUR]) in Patients with Glioblastoma (GBM): Results for Cohort B (DUR Monotherapy), Bevacizumab (BEV) Naïve Patients with Recurrent GBM David A. Reardon, MD, Boston, MA 2:40 p.m.–3:00 p.m. Redefining the Cellular Architecture of Adult and Pediatric Glioblastomas Through Large-scale Single-cell Analyses Mariella Filbin, MD, PhD, Boston, MA
2:00 p.m.–2:20 p.m. Transformation of Tumor Endothelial Cells to Mesenchymal Stem Cell-like Cells Induces Therapy Resistance in Glioblastoma Menggui Huang, PhD, Philadelphia, PA
B:8.5” T:8.25” S:7.25”
FIGHT BACK EARLY WITH GILENYA® (fingolimod) 4/23–4/26 | Boston, MA
KRISTIN
“I got the tears out of my system and got ready for my fight.”
STACEY “My story is a comeback story.”
People who have experience with GILENYA. They have been compensated for their time.
GILENYA is a registered trademark of Novartis AG.
Step inside the ring at booth 547
Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080
JAMES “You can keep going after your diagnosis.”
Hear from real GILENYA patients in the Patient Video Center Explore the MOA module, and watch the immersive MOA video See “The Story of GILENYA: Inspired by Nature, Refined by Science”
© 2017 Novartis
3/17
T-GYA- 1342233
Today’s Experiential Learning Area Highlights Get ready to experience interactive—and totally flexible—new ways of exploring, engaging, and learning at today’s Experiential Learning Areas. Each area will offer a variety of real-world experiences designed to engage you intellectually, emotionally, and socially while serving up fresh ideas to help you personally and professionally.
Highlights: Axon Registry® 8:30 a.m.–9:00 a.m. Maximize Your Value Experiential Learning Area Lyell K. Jones, MD, FAAN AAN Resident and Fellow Members: Meet and Greet 12:00 p.m.–12:30 p.m. Navigating Your Career Experiential Learning Area Eugene Scharf, MD Abhimanyu Mahajan, MD
The Gamification of Neurology Education 1:00 p.m.–2:00 p.m. Education and Publications Station Experiential Learning Area Zachary London, MD, FAAN MACRA Overview 2:00 p.m.–2:30 p.m. Maximize Your Value Experiential Learning Area Lyell K. Jones, MD, FAAN
NINDS Day MIPS: What Is MIPS and How Do I Participate? 3:00 p.m.–3:30 p.m. Maximize Your Value Experiential Learning Area Anup D. Patel, MD Hall of Presidents: Neurology Through the Years 3:00 p.m.–4:00 p.m. HeadTalks Experiential Learning Area
Terrence L. Cascino, MD, FAAN Stanley Fahn MD, FAAN Robert C. Griggs, MD, FAAN Francis I. Kittredge Jr. MD,FAAN Sandra F. Olson MD, FAAN Stephen M. Sergay, MB BCh, FAAN Thomas R. Swift, MD, FAAN Roger N. Rosenberg, MD, FAAN
Research Corner Experiential Learning Area 8:30 a.m.–9:00 a.m. NIH Funding and Professional Development Opportunities for Diverse Researchers Michelle Jones-London, PhD 1:00 p.m.–1:30 p.m. Introduction and Overview of NIH Funding Walter Koroshetz, MD, FAAN 2:30 p.m.–3:30 p.m. Panel of NIH Grant Review Committees Moderated by Robin Conwit, MD; Adam Hartman, MD; Codrin Lumgu, MD; and Michael Oshinsky, MD AAN’s APMs: Management and Participation 4:00 p.m.–4:30 p.m. Maximize Your Value Experiential Learning Area James N. Goldenberg, MD, FAAN
Industry Therapeutic Update from Novartis Pharma AG The tightrope of MS: maintaining balance on the disease continuum Tuesday 25 April 2017, 19:00–20:30 Plaza Ballroom Seaport Hotel & World Trade Center, Boston, MA, USA This Industry Therapeutic Update could mention product data not aligned with the approved label in your country. For this reason we advise you that the contents are not intended for some countries, including the US. This is not a CME programme nor will CME credits be given for attendance.
This meeting is not an AAN-endorsed event.
© 2017 Novartis Pharma AG GMCC: GLNS/GILE/0193f eMED: M-GYA-1342697 Date of preparation: March 2017
Novartis Pharma AG CH-4056 Basel, Switzerland www.novartis.com
F O R A D U LT S W I T H TA R D I V E D Y S K I N E S I A ( T D ) , T H E F I R S T A N D O N LY I N D I C AT E D T R E AT M E N T
I N T R O D U C I N G
NO FDA-APPROVED TREATMENT HAS EXISTED—UNTIL NOW.
Discover a new treatment for your adult TD patients Visit us at booth #585 Important Information INDICATION & USAGE INGREZZA™ (valbenazine) capsules is indicated for the treatment of adults with tardive dyskinesia.
IMPORTANT SAFETY INFORMATION WARNINGS & PRECAUTIONS Somnolence INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.
QT Prolongation INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
ADVERSE REACTIONS The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >placebo) include: anticholinergic effects, balance disorders/ falls, headache, akathisia, vomiting, nausea, and arthralgia. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. Please see the adjacent page for brief summary of Prescribing Information and visit www.INGREZZA.com for full Prescribing Information. REFERENCE: INGREZZA [package insert]. San Diego, CA: Neurocrine Biosciences, Inc; 2017.
©2017 Neurocrine Biosciences, Inc. All Rights Reserved. CP-VBZ-US-0112 04/17
for oral use
Brief Summary: for full Prescribing Information and Patient Information, refer to package insert. INDICATIONS AND USAGE
INGREZZA is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of adults with tardive dyskinesia.
WARNINGS AND PRECAUTIONS
Somnolence INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA. QT Prolongation INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. In patients taking a strong CYP2D6 or CYP3A4 inhibitor, or who are CYP2D6 poor metabolizers, INGREZZA concentrations may be higher and QT prolongation clinically significant. For patients who are CYP2D6 poor metabolizers or are taking a strong CYP2D6 inhibitor, dose reduction may be necessary. For patients taking a strong CYP3A4 inhibitor, reduce the dose of INGREZZA to 40 mg once daily. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.
Endocrine Disorders: blood glucose increased General Disorders: weight increased Infectious Disorders: respiratory infections Neurologic Disorders: drooling, dyskinesia, extrapyramidal symptoms (non-akathisia) Psychiatric Disorders: anxiety, insomnia During controlled trials, there was a dose-related increase in prolactin. Additionally, there was a dose-related increase in alkaline phosphatase and bilirubin, suggesting a potential risk for cholestasis.
DRUG INTERACTIONS
Drugs Having Clinically Important Interactions with INGREZZA Table 2: Clinically Significant Drug Interactions with INGREZZA Monoamine Oxidase Inhibitors (MAOIs) Clinical Implication:
Prevention or Management: Examples: isocarboxazid, phenelzine, selegiline Strong CYP3A4 Inhibitors Clinical Implication:
ADVERSE REACTIONS
The following adverse reactions are discussed in more detail in other sections of the labeling: • Somnolence • QT Prolongation Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Prevention or Management: Examples: Strong CYP2D6 Inhibitors
The safety of INGREZZA was evaluated in 3 placebo-controlled studies, each 6 weeks in duration (fixed dose, dose escalation, dose reduction), including 445 patients. Patients were 26 to 84 years of age with moderate to severe tardive dyskinesia and had concurrent diagnoses of mood disorder (27%) or schizophrenia/schizoaffective disorder (72%). The mean age was 56 years. Patients were 57% Caucasian, 39% African-American, and 4% other. With respect to ethnicity, 28% were Hispanic or Latino. All subjects continued previous stable regimens of antipsychotics; 85% and 27% of subjects, respectively, were taking atypical and typical antipsychotic medications at study entry. Adverse Reactions Leading to Discontinuation of Treatment A total of 3% of INGREZZA treated patients and 2% of placebo-treated patients discontinued because of adverse reactions. Common Adverse Reactions Adverse reactions that occurred in the 3 placebo-controlled studies at an incidence of ≥2% and greater than placebo are presented in Table 1. Table 1: Adverse Reactions in 3 Placebo-Controlled Studies of 6-week Treatment Duration Reported at ≥2% and >Placebo INGREZZA (n=262) (%)
Placebo (n=183) (%)
Concomitant use of INGREZZA with strong CYP2D6 inhibitors may increase the exposure (Cmax and AUC) to valbenazine’s active metabolite compared with the use of INGREZZA alone. Increased exposure of active metabolite may increase the risk of exposure-related adverse reactions.
Prevention or Management:
Consider reducing INGREZZA dose based on tolerability when INGREZZA is coadministered with a strong CYP2D6 inhibitor.
Examples:
paroxetine, fluoxetine, quinidine
10.9%
4.2%
Anticholinergic effects (dry mouth, constipation, disturbance in attention, vision blurred, urinary retention)
5.4%
4.9%
Balance disorders/fall (fall, gait disturbance, dizziness, balance disorder)
4.1%
2.2%
Headache Akathisia (akathisia, restlessness)
3.4% 2.7%
2.7% 0.5%
2.6% 2.3%
0.6% 2.1%
2.3%
0.5%
Strong CYP3A4 Inducers Clinical Implication:
Prevention or Management: Examples: Digoxin
General Disorders Somnolence (somnolence, fatigue, sedation) Nervous System Disorders 1
Gastrointestinal Disorders Vomiting Nausea Musculoskeletal Disorders Arthralgia 1
Within each adverse reaction category, the observed adverse reactions are listed in order of decreasing frequency.
Other Adverse Reactions Observed During the Premarketing Evaluation of INGREZZA Other adverse reactions of ≥1% incidence and greater than placebo are shown below. The following list does not include adverse reactions: 1) already listed in previous tables or elsewhere in the labeling, 2) for which a drug cause was remote, 3) which were so general as to be uninformative, 4) which were not considered to have clinically significant implications, or 5) which occurred at a rate equal to or less than placebo.
Concomitant use of INGREZZA with strong CYP3A4 inhibitors increased the exposure (Cmax and AUC) to valbenazine and its active metabolite compared with the use of INGREZZA alone. Increased exposure of valbenazine and its active metabolite may increase the risk of exposure-related adverse reactions. Reduce INGREZZA dose when INGREZZA is coadministered with a strong CYP3A4 inhibitor. itraconazole, ketoconazole, clarithromycin
Clinical Implication:
Variable and Fixed Dose Placebo-Controlled Trial Experience
Adverse Reaction1
Concomitant use of INGREZZA with MAOIs may increase the concentration of monoamine neurotransmitters in synapses, potentially leading to increased risk of adverse reactions such as serotonin syndrome, or attenuated treatment effect of INGREZZA. Avoid concomitant use of INGREZZA with MAOIs.
Concomitant use of INGREZZA with a strong CYP3A4 inducer decreased the exposure of valbenazine and its active metabolite compared to the use of INGREZZA alone. Reduced exposure of valbenazine and its active metabolite may reduce efficacy. Concomitant use of strong CYP3A4 inducers with INGREZZA is not recommended. rifampin, carbamazepine, phenytoin, St. John’s wort1
Clinical Implication:
Concomitant use of INGREZZA with digoxin increased digoxin levels because of inhibition of intestinal P-glycoprotein (P-gp).
Prevention or Management:
Digoxin concentrations should be monitored when co-administering INGREZZA with digoxin. Increased digoxin exposure may increase the risk of exposure related adverse reactions. Dosage adjustment of digoxin may be necessary.
The induction potency of St. John’s wort may vary widely based on preparation.
Drugs Having No Clinically Important Interactions with INGREZZA Dosage adjustment for INGREZZA is not necessary when used in combination with substrates of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2E1, or CYP3A4/5 based on in vitro study results.
OVERDOSAGE
Human Experience The pre-marketing clinical trials involving INGREZZA in approximately 850 subjects do not provide information regarding symptoms with overdose. Management of Overdosage No specific antidotes for INGREZZA are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. If an overdose occurs, consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org). For further information on INGREZZA, call 84-INGREZZA (844-647-3992). Distributed by: Neurocrine Biosciences, Inc. San Diego, CA 92130 INGREZZA is a trademark of Neurocrine Biosciences, Inc. CP-VBZ-US-0203 04/17
Poster Session III Opens This Morning at 8:30, Posters Grouped by Topic “Neighborhoods” Today’s Poster Session III will run from 8:30 a.m. to 7:00 p.m. in Exhibit Hall B of the convention center, with presenter standby from 5:30 p.m. to 7:00 p.m. New this year, we’ve clustered all topic-related posters together into “neighborhoods” to enhance your discussions and make the posters easier to navigate. Neighborhoods include: Group A: Movement Disorders Group B: Practice, Policy, and Ethics; Sleep; Cerebrovascular Disease and Interventional Neurology ePosters Group C: Aging and Dementia Group D: Cerebrovascular Disease and Interventional Neurology Poster Discussion Group E: Neuromuscular and Clinical Neurophysiology (EMG) Group F: Neuro-oncology; Neurocritical Care; Child Neurology Group G: Epilepsy/Clinical Neurophysiology (EEG) Group H: Cerebrovascular Disease and Interventional Neurology; Infectious Disease; Global Health Group I: MS and CNS Inflammatory Disease
Cerebrovascular Disease and Interventional Neurology ePoster Session Be sure and check out today’s interactive, touchscreen ePosters at the virtual hall kiosk for another great opportunity to further explore scientific posters.
Cerebrovascular Disease and Interventional Neurology Lunchtime Poster Discussion Session If you can’t get enough cutting-edge science, join today’s lunchtime Poster Discussion Session at the poster discussion stage between 11:45 a.m. and 12:45 p.m., where a group of 10 abstracts will be presented by their authors in a five-minute data blitz with a moderator leading stimulating discussion on the content of the selected posters.
Remaining Poster Session Schedule Poster Session IV Wednesday, April 26: 8:30 a.m.–7:00 p.m. / author standby from 5:30 p.m.–7:00 p.m.
Poster Session V Thursday, April 27: 8:30 a.m.–7:00 p.m. / author standby from 5:30 p.m.–7:00 p.m.
Poster Session VI Friday, April 28: 8:30 a.m.–5:30 p.m. / author standby from 4:00 p.m.–5:30 p.m.
New SUDEP Guideline Reviewed at Press Conference Sudden unexpected death in epilepsy (SUDEP) is an uncommon but known complication of epilepsy. SUDEP is the sudden, unexpected death of a person with epilepsy who is otherwise healthy. There is evidence that SUDEP is rare in children. Each year, 1 in 4,500 children with epilepsy will die of SUDEP. In adults, 1 in 1,000 with epilepsy will die each year of SUDEP. The cause of death in SUDEP is unknown, but evidence does indicate certain risk factors. The occurrence of generalized tonic-clonic seizures (GTCS) is the most important risk factor for SUDEP. The greater the frequency of GTCS, the greater the risk of SUDEP.
continued from cover
“For persons with epilepsy who continue to experience GTCS, clinicians should continue to actively manage epilepsy therapies to potentially reduce seizures, while incorporating patient preferences and weighing the risks and benefits of any new approach. Other risk factors with less strong evidence for their effect on SUDEP occurrence are covered
in the guideline and can inform a more detailed discussion between the patient and the treating clinician.” Read the guideline and access PDF summaries for clinicians and patients, and a slide presentation set on AAN.com. For more information, contact Jon Dittman at jdittman@aan.com or (612) 928-6056.
“Clinicians should counsel patient accurately on the incidence rates of SUDEP in different populations and address treatment of generalized tonicclonic seizures to reduce the risk of SUDEP in patients with epilepsy,” said lead guideline author Cynthia L. Harden, MD.
Tuesday, April 25, 2017 • AANextra
13
Get a Presidential View of How Neurology Has Evolved Join past leaders of the AAN at the HeadTalks stage in the Experiential Learning Area for “Hall of Presidents: Neurology Through the Years,” to be held today from 3:00 p.m. to 4:00 p.m. This session features a panel of past AAN presidents, including outgoing President Terrence L. Cascino, MD, FAAN, who will discuss how neurology has changed throughout the years.
Scheduled to attend are: Terrence L. Cascino, MD, FAAN
Robert C. Griggs, MD, FAAN
Francis I. Kittredge, Jr., MD, FAAN
Steven P. Ringel, MD, FAAN
Roger N. Rosenberg, MD, FAAN
Stephen M. Sergay, MB BCh, FAAN
Thomas R. Swift, MD, FAAN
Visit our booth for information about a treatment option for a rare disease Learn more about KEVEYIS® and Strongbridge CareConnection patient support at Booth 889. 900 Northbrook Drive, Suite 200 Trevose, PA 19053 United States www.KEVEYIS.com www.strongbridgebio.com © 2017 Strongbridge Biopharma plc STRONGBRIDGE BIOPHARMA™ is a trademark of Strongbridge Biopharma plc. KEVEYIS® is a registered trademark licensed exclusively in the US to Strongbridge Biopharma plc. KEV026-05 03/2017
INDUSTRY THERAPEUTIC UPDATE FROM GENENTECH, INC. Join us for an Interactive Expert Panel Discussion featuring:
Stephen L. Hauser, MD Director, UCSF Weil Institute for Neurosciences Professor & Chair, Department of Neurology University of California, San Francisco School of Medicine San Francisco, California
Revere (Rip) Philip Kinkel, MD Director, UCSD MS Program Professor of Neurosciences & Clinical Neurology Director University of California, San Diego San Diego, California
Barry Singer, MD
Director of the MS Center for Innovations in Care at Missouri Baptist Medical Center Missouri Baptist Medical Center Saint Louis, MO
Westin Waterfront Hotel 425 Summer Street Boston, MA 02210
Waterfront Marina Ballroom Tuesday, April 25, 2017 7:00 PM – 9:15 PM
In accordance with the PhRMA Code on Interactions with Healthcare Professionals, attendance at this promotional program is limited to healthcare professionals. Minnesota, Vermont, and Federal Entities have restrictions on receiving in-kind benefits (eg, meals, valet parking) at company-sponsored events. You are accountable for understanding such restrictions and complying with them. If you are licensed in or affiliated with any of these states or federal agencies, Genentech policies may restrict you from consuming any portion of the Genentech-sponsored meal at this program or from receiving any other in-kind benefit from Genentech (eg, valet parking) in connection with the program. Please note that this is a promotional, non-CME program, and no CME credits will be given for attendance. This is not an official event of the 2017 AAN Annual Meeting, and it is not sponsored or endorsed by AAN. This program is sponsored by Genentech, Inc.
Š 2017 Genentech USA, Inc. All rights reserved. Printed in the USA. OCR/030117/0026 04/17
TR ANSFOR M THE TR E ATMENT OF PARKINSON’S DISEASE PSYCHOSIS NUPLAZID® (pimavanserin) IS THE FIRST AND ONLY FDA-approved therapy proven to reduce the symptoms of hallucinations and delusions without impacting motor function1
Change your outlook on Parkinson’s disease psychosis. In vitro, NUPLAZID targets 5-HT2A and 5-HT2C receptors while demonstrating no appreciable binding affinity for dopamine, histamine, muscarinic, or adrenergic receptors. With a proven safety profile and no impact on motor function, once-daily NUPLAZID 34 mg can be prescribed with confidence.1
Visit booth #489 to experience the transformation with the Oculus virtual reality headset.
Indication NUPLAZID is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
Important Safety Information for NUPLAZID (pimavanserin) 17-mg Tablets WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis. QT Interval Prolongation: NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination
with other drugs known to prolong QT interval including Class 1A antiarrhythmics or Class 3 antiarrhythmics, certain antipsychotic medications, and certain antibiotics. NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and presence of congenital prolongation of the QT interval. Adverse Reactions: The most common adverse reactions (≥2% for NUPLAZID and greater than placebo) were peripheral edema (7% vs 2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination (5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs <1%). Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole) increase NUPLAZID concentrations. Reduce the NUPLAZID dose by one-half.
Strong CYP3A4 inducers may reduce NUPLAZID exposure, only if the potential benefit justifies the potential risk to monitor for reduced efficacy. Increase in NUPLAZID dosage the mother and fetus. may be needed. Pediatric Use: Safety and efficacy have not been established Renal Impairment: No dosage adjustment for NUPLAZID is in pediatric patients. needed in patients with mild to moderate renal impairment. Dosage and Administration Use of NUPLAZID is not recommended in patients with Recommended dose: 34 mg per day, taken orally as two severe renal impairment. 17-mg tablets once daily, without titration. Hepatic Impairment: Use of NUPLAZID is not You are encouraged to report negative side effects of recommended in patients with hepatic impairment. prescription drugs to the FDA. Visit www.fda.gov/medwatch NUPLAZID has not been evaluated in this patient or call 1-800-FDA-1088. You can also call ACADIA population. Pharmaceuticals Inc. at 1-844-4ACADIA (1-844-422-2342). Pregnancy: Use of NUPLAZID in pregnant women has not been evaluated and should therefore be used in pregnancy See Brief Summary of Prescribing Information on adjacent pages. Reference: 1. NUPLAZIDŽ (pimavanserin) prescribing information, ACADIA. Š2017 ACADIA Pharmaceuticals Inc. All rights reserved. NU-0584 03/17.
T:6.875”
NUPLAZID™ (pimavanserin) tablets, for oral use. Rx only Brief Summary: This information is not comprehensive. Visit www.NUPLAZID.com to obtain the FDA-approved product labeling or call 1-844-422-2342. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. NUPLAZID is not approved for the treatment of patients with dementia-related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis. 1 INDICATIONS AND USAGE NUPLAZID™ is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
and/or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval. 6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Increased Mortality in Elderly Patients with DementiaRelated Psychosis • QT Interval Prolongation Clinical Trial Experience The clinical trial database for NUPLAZID consists of over 1200 subjects and patients exposed to one or more doses of NUPLAZID. Adverse reactions that occurred in 6-week, placebo-controlled studies and that were reported at an incidence of ≥2%, and >placebo are presented in the following table.
2 DOSAGE AND ADMINISTRATION The recommended dose of NUPLAZID is 34 mg, taken orally as two 17-mg strength tablets once daily, without titration.
Adverse Reactions (≥2% and >Placebo)
• Coadministration with Strong CYP3A4 Inhibitors The recommended dose of NUPLAZID when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole) is 17 mg, taken orally as one tablet once daily. • Coadministration with Strong CYP3A4 Inducers Monitor patients for reduced efficacy if NUPLAZID is used concomitantly with strong CYP3A4 inducers; an increase in NUPLAZID dosage may be needed.
5 WARNINGS AND PRECAUTIONS Increased Mortality in Elderly Patients with DementiaRelated Psychosis Antipsychotic drugs increase the all-cause risk of death in elderly patients with dementia-related psychosis. Analyses of 17 dementia-related psychosis placebo-controlled trials (modal duration of 10 weeks and largely in patients taking atypical antipsychotic drugs) revealed a risk of death in the drug-treated patients of between 1.6- to 1.7-times that in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in placebo-treated patients. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. NUPLAZID is not approved for the treatment of patients with dementia related psychosis unrelated to the hallucinations and delusions associated with Parkinson’s disease psychosis. QT Interval Prolongation NUPLAZID prolongs the QT interval. The use of NUPLAZID should be avoided in patients with known QT prolongation or in combination with other drugs known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), certain antipsychotic medications (e.g., ziprasidone, chlorpromazine, thioridazine), and certain antibiotics (e.g., gatifloxacin, moxifloxacin). NUPLAZID should also be avoided in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes
NUPL16CDLA0961_Brief_Summary_ASize_r3.indd 1
Placebo
N = 202
N = 231
Nausea
7%
4%
Peripheral edema
7%
2%
Confusional state
6%
3%
Hallucination
5%
3%
Constipation
4%
3%
Gait disturbance
2%
<1%
Hallucination includes visual, auditory, tactile, and somatic hallucinations
a
7 DRUG INTERACTIONS QT Interval Prolongation Concomitant use of drugs that prolong the QT interval may add to the QT effects of NUPLAZID and increase the risk of cardiac arrhythmia. Avoid the use of NUPLAZID in combination with other drugs known to prolong QT interval. Strong CYP3A4 Inhibitors Concomitant use of NUPLAZID with a strong CYP3A4 inhibitor increases pimavanserin exposure. If NUPLAZID is used with a strong CYP3A4 inhibitor, reduce the dosage of NUPLAZID. Strong CYP3A4 Inducers Concomitant use of a strong CYP3A4 inducer may reduce pimavanserin exposure resulting in a potential decrease in efficacy. Patients should be monitored for reduced efficacy and an increase in dosage may be needed if NUPLAZID is used concomitantly with strong CYP3A4 inducers. 8 USE IN SPECIFIC POPULATIONS Pregnancy: There are no data on NUPLAZID use in pregnant women that would allow assessment of the drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies, no adverse developmental effects were seen when pimavanserin was administered orally to rats or rabbits during the period of organogenesis at doses up to 10- or 12-times the maximum recommended human dose (MRHD) of 34 mg/day, respectively. Administration of pimavanserin to pregnant rats during pregnancy and lactation resulted in maternal toxicity and lower pup survival and body weight at doses which are 2-times the MRHD of 34 mg/day.
9/27/16 6:01 PM
T:9.75”
4 CONTRAINDICATIONS None.
NUPLAZID 34 mg
Preferred Term
T:6.875”
Lactation: There is no information regarding the presence of pimavanserin in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NUPLAZID and any potential adverse effects on the breastfed infant from NUPLAZID or from the underlying maternal condition. Pediatric Use Safety and effectiveness of NUPLAZID have not been established in pediatric patients. Geriatric Use No dose adjustment is required for elderly patients. Parkinson’s disease is a disorder occurring primarily in individuals over 55 years of age. The mean age of patients enrolled in the 6-week clinical studies with NUPLAZID was 71 years, with 49% 65-75 years old and 31% >75 years old. In the pooled population of patients enrolled in 6-week, placebocontrolled studies (N=614), 27% had MMSE scores from 21 to 24 compared to 73% with scores ≥25. No clinically meaningful differences in safety or effectiveness were noted between these two groups.
17 PATIENT COUNSELING INFORMATION Concomitant Medication Advise patients to inform their healthcare providers if there are any changes to their current prescription or over-thecounter medications, since there is a potential for drug interactions.
CAUTION: Federal law prohibits dispensing without prescription. NUPLAZID™ is a trademark of ACADIA Pharmaceuticals Inc. Distributed by: ACADIA Pharmaceuticals Inc. San Diego, CA 92130 NU-0381 09/16.
Renal Impairment No dosage adjustment for NUPLAZID is needed in patients with mild to moderate (CrCL ≥30 mL/min, Cockcroft-Gault) renal impairment. Use of NUPLAZID is not recommended in patients with severe renal impairment (CrCL <30 mL/min, Cockcroft-Gault). NUPLAZID has not been evaluated in this patient population. T:9.75”
Hepatic Impairment Use of NUPLAZID is not recommended in patients with hepatic impairment. NUPLAZID has not been evaluated in this patient population. 9 DRUG ABUSE AND DEPENDENCE Controlled Substance NUPLAZID is not a controlled substance. Abuse NUPLAZID has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. While short-term, placebo-controlled and long-term, openlabel clinical trials did not reveal increases in drug-seeking behavior, the limited experience from the clinical trials do not predict the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. 10 OVERDOSAGE Human Experience The pre-marketing clinical trials involving NUPLAZID in approximately 1200 subjects and patients do not provide information regarding symptoms with overdose. In healthy subject studies, dose limiting nausea and vomiting were observed. Management of Overdose There are no known specific antidotes for NUPLAZID. In managing overdose, cardiovascular monitoring should commence immediately and should include continuous ECG monitoring to detect possible arrhythmias. If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine should not be used, as they have the potential for QT-prolonging effects that might be additive to those of NUPLAZID. Consider the long plasma half-life of pimavanserin (about 57 hours) and the possibility of multiple drug involvement.
NUPL16CDLA0961_Brief_Summary_ASize_r3.indd 2
9/27/16 6:01 PM
Tweets of the Day B
alaji Krishnaiah @FastTpa
Green bow tie presence in #AANAM. Spreading awareness on Advocacy. @AANMember
K
N
eal S Parikh @NealSParikhMD
"3 sneezes, that's a sneizure!" heard at #AANAM. Adding to neuro bad #dadjokes repertoire.
athrin LaFaver @LaFaverMD
G
Inspired by the increase in female plenary speakers at this year's #AANAM - Amaal Starling's talk on migraine therapy was a great example!
urdesh Singh Bedi @GurdeshBedi
Gurdesh Singh Bedi Retweeted Derek Brandt—Very inspiring listening to two of the most dynamic congressmen out there. @RepRonKind @RepBera #AANAM
D
erek Brandt @DerekBrandtDC
Happening now! Reps. Ron Kind and Dr. Ami Bera speaking to @AANMember during #AANAM
P
artha Thirumala @Yes2healthierPA
@AANMember with international PALF graduates #AANAM
Significant Clinical Trials to Be Covered in This Morning’s Clinical Trials Plenary Session continued from cover Longitudinal Effect of Eteplirsen Versus Historical Control on Ambulation in Duchenne Muscular Dystrophy Jerry R. Mendell, MD, FAAN The Research Institute at Nationwide Children’s Hospital, Columbus, OH
Jerry R. Mendell, MD, FAAN
Cannabidiol (CBD) Reduces Convulsive Seizure Frequency in Dravet Syndrome: Results of a Multicenter, Randomized, Controlled trial (GWPCARE1) J. Helen Cross, PhD UCL-Institute of Child Health, London, United Kingdom
J. Helen Cross, PhD
Kids Are Not Just Little Adults: The Childhood and Adolescent Migraine Prevention Trial (CHAMP) Scott Powers, PhD Cincinnati Children’s Hospital, Cincinnati, OH
MGTX: Results of the Multinational Thymectomy Trial in Nonthymomatous Myasthenia Gravis Gil I. Wolfe, MD, FAAN University at Buffalo, Buffalo, NY Scott Powers, PhD Gil I. Wolfe, MD, FAAN
Efficacy of Siponimod in Secondary Progressive Multiple Sclerosis: Results of the Phase 3 Study Ludwig Kappos, MD University Hospital Basel, Basel, Switzerland
Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention: Primary Results of the STRIVE Trial Peter Goadsby, MD, PhD University of California San Francisco, San Francisco, CA
Ludwig Kappos, MD Peter Goadsby, MD, PhD
A 2-year Multidomain Intervention of Diet, Exercise, Cognitive Training, and Vascular Risk Monitoring Versus Control to Prevent Cognitive Decline in At-risk Elderly People (FINGER): A Randomized Controlled Trial Miia Kivipelto, MD University of Kuopio, Kuopio, Finland Miia Kivipelto, MD
AVXS-101 Phase 1 Gene Therapy Clinical Trial in SMA Type 1: Event Free Survival and Achievement of Developmental Milestones Jerry R. Mendell, MD, FAAN The Research Institute at Nationwide Children's Hospital, Columbus, OH
Tomorrow’s Frontiers in Neuroscience Plenary Session to Focus on Translational Research Translational research related to clinical issues of importance will be the focus of Wednesday morning’s Frontiers in Neuroscience Plenary Session when six physician-scientists outline their recent research findings, along with the clinical implications. The session will take place starting at 9:15 a.m. in Exhibit Hall A.
Jerry R. Mendell, MD, FAAN
Tuesday, April 25, 2017 • AANextra
21
If You Liked What Bayer Gave Your Patients in 2016
See What‘s Coming in 2017.
Coming Soon Be one of the first to know. www.mytreatmentexperience.com/hcp
BAYER and the Bayer Cross are registered trademarks of Bayer. ©2017 Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981. All rights reserved. PP-721-US-0681 March 2017
Palatucci Forum Leads to Fulfillment of Member’s Dreams for Patients More than 400 AAN members have participated in the Palatucci Advocacy Leadership Forum. They have been changing how neurology is practiced across the world, from Pakistan to Austria to Wyoming—and to St. Croix Falls, WI, where Gurdesh Bedi, MD, is the first medical director of the Kinisi Institute of Movement, a new musculoskeletal center serving western Wisconsin and eastern Minnesota. Bedi, a son of physicians in his native India, had trained in the US and taken
up practice in this scenic riverside area. It was a successful practice, but he didn’t know what to do next. He wanted to build a larger center, advocate for his patients’ rights, be a policy maker, change the world. But he didn’t know where to start. Bedi applied to attend the 2014 forum after an enthusiastic recommendation from a “PALFer” from the first class. He was accepted, and his life was changed by the weekend of intensive training and the AAN members he met who would become his best friends and mentors. “I was like Alice in Wonderland,” he said later. “I got to learn and debate with
Bedi with his fellow staff at the Kinisi Institute of Movement
Set Yourself Apart Get the recognition you deserve. Add the Fellow of the AAN (FAAN) designation to your already impressive credentials. Learn how at AAN.com/view/FAAN.
policy makers and system rebels, local heroes and cross-border caregivers, dreamers of starts-ups and serial entrepreneurs. These discussions were stimulating, Gurdesh Bedi, MD and my world view radically expanded.” The lesson that change doesn’t always have to happen at the highest levels revolutionized Bedi’s thinking. “I discovered that I was a believer in change from the ground up. So I went back and got engaged in a Rotary Club in my town.” Soon he signed up for the county and the Wisconsin state medical societies. Within a month of PALF, he was sitting on two Wisconsin medical councils, presiding over its young physician society, and on the way to becoming Wisconsin’s delegate to the AMA. Within a year, he was on the board of the 175-year-old, 13,000-member Wisconsin medical society. Around the same time, he found his niche at the Continued on page 24 u
Bedi says the Palatucci Forum works on the principle of putting the patient in the center of the conversation.
national level and got involved with the efforts of the AAN and AMA in Washington, DC. The Mount Sinai Hospital is ranked No.12 in Neurology &
Neurosurgery
by
U.S. News & World Report,
2016-17. Our world-class specialists are commi ed to the discovery of new treatments for neurological conditions and hold faculty appointments at the Icahn School of Medicine at Mount Sinai, ranked among the nation’s top medical schools by U.S. News & World Report. • Comprehensive Stroke Center • Bendheim Parkinson and Movement Disorders Center • Corinne Goldsmith Dickinson Center for Multiple Sclerosis • Center for Headache and Facial Pain • Neuromuscular Disease Division • Neurocritical Care • Neurovestibular and Balance Disorders • Center for Cognitive Health and Alzheimer’s Disease Research Center • Neuro-Infectious Diseases and NeuroAIDS Program • Epilepsy Center • Pediatric Neurology • Neuro-Oncology Program • Neuro-Ophthalmology Program
1-800-MD-SINAI • mountsinai.org/msneuro
“I also realized that change needed to happen in my everyday microenvironment. I had a healthy, traditional practice. I personally did well in this environment. I grew, controlled my schedule, had good support staff, and had a good income. But all along, as much as I loved my job, I had felt that something was missing. I had pitched ideas of ambitious projects to my hospital leadership and board before, but knew that I wasn’t communicating right. On the flight back from my rookie PALF year, I realized where the gap was. PALF helped me realize it.” Bedi said the Palatucci Forum works on the principle of putting the patient in the center of the conversation. After PALF 2014, Bedi saw having a logic-based, common-sense, respectful attitude toward patients as a right, and not a forlorn desire. The forum gave him the tools to restate his previously hazy view of this utopian clinical approach into achievable action plans, setting SMART (Specific, Measurable, Attainable, Realistic, Timely) goals. With this revised approach, his team approached the hospital board with a hefty project to redesign its clinics from the ground up (using a PALF-inspired SMART action plan). The result is the Kinisi Institute for Movement (a name that embodies the principles behind this new musculoskeletal center) and the first of these smart-clinics launched in July 2016, with Bedi appointed as the center’s first medical director. The clinic and its systems have been designed by staff who have been trained to anticipate, rather than react to, patient needs and
expectations. Bedi now feels he has a real shot at making health care more humane in the region. “None of this would have ever been possible, may have not even been imagined, had I not been urged to apply for the forum and been accepted just two years ago,” Bedi says. “I wrote more emails, had clearer thoughts, and was much better skilled to handle organizational challenges after PALF. It was such an intense intellectual high that I craved a second shot, and went back as an advisor in 2015. The results were even better—like
AT THE AAN ANNUAL MEETING
DISCOVER ADVANCED NEUROMUSCULAR TESTING Muscle biopsy Acid a-glucosidase
a booster vaccination.” He wanted to participate a third time, in 2016, but a family situation prevented him.
Various blood tests
The Palatucci Forum is one of several programs offered by the AAN to train leaders to meet the many challenges in today’s world of neurology. What Bedi says about the forum can be said of all of the leadership programs.
Nerve conduction tests
“I don’t think that the Shakespearean concept of leaders being born or having leadership thrust upon them is true anymore. Leadership cannot be gifted or thrust upon any unprepared individual. It must be acquired—through hard work, skills, development, and training. While capability is a basic requirement, molding capable individuals into perpetual problem solvers requires structured leadership training. That is the road the Palatucci Forum opened for me.”
Electrocardiograms Pulmonary function tests Reflex testing X-rays Magnetic resonance imaging Sleep studies Targeted DNA analysis1 Learn more about panel testing for neuromuscular disorders—including Pompe disease. A complimentary program is available for targeted DNA analysis of up to 31 separate conditions.1
Testing early can help impact a 13-year diagnostic delay for Pompe disease.* 2-4
AAN and WFN Leaders Meet
Visit Sanofi Genzyme at Booth #729 to learn more.
* Based on the median diagnostic gap.
Leaders of the AAN and World Federation of Neurology gathered during the meeting, along with Prof. Günther Deuschl, president of the European Academy of Neurology. Front row, from left: WFN Trustee Riadh Gouider, MD; Dueschl; WFN President Raad Shakir, MD; AAN President Terrence L.Cascino, MD, FAAN; AAN President Elect Ralph L. Sacco, MD, FAAN. Back row, from left: WFN Treasurer Prof. Richard Stark; WFN Secretary General Wolfgang Grisold, MD; WFN Elected Trustee Prof. Morris Freedman; AAN CEO Catherine M. Rydell, CAE; WFN First Vice President Prof. William Carroll; WFN Elected Trustee Steven L. Lewis, MD, FAAN.
References: 1. Limb Girdle Muscular Dystrophy Consortium. http://www. lgmd-diagnosis.org/physician-portal. Accessed March 30, 2015. 2. Toscano A, Montagnese F, Musumeci O. Early is better? A new algorithm for early diagnosis in late-onset Pompe disease (LOPD). Acta Myol. 2013;32(2):78-81. 3. Kishnani PS, Amartino HM, Lindberg C, Miller TM, Wilson A, Keutzer J; Pompe Registry Boards of Advisors. Timing of diagnosis of patients with Pompe disease: data from the Pompe Registry. Am J Med Genet A. 2013;161A(10):2431-2443. 4. Winkel LP, Hagemans ML, van Doorn PA, et al. The natural course of non-classic Pompe’s disease; a review of 225 published cases. J Neurol. 2005;252(8):875-884.
www.pompe.com ©2017 Genzyme Corporation. All rights reserved. GZUS.PD.15.07.1915(1)
Enhance your Annual Meeting experience with Annual Meeting On Demand. There is no better place than the AAN Annual Meeting for a high-quality educational experience in neurology. With the robust offering of concurrent courses available during the meeting, it is impossible to attend every one. Annual Meeting On Demand delivers captured content from the Annual Meeting to your doorstep so that you can experience the full value of the meeting. Annual Meeting On Demand is a CME accredited comprehensive digital library with more than 500 hours1 of presentations from the 2017 AAN Annual Meeting including syllabi for 200+ programs. Features of Annual Meeting On Demand include: • Online access to content within 24 hours of live presentations. • Integrated online CME testing. • An advanced search engine that delivers a direct link to the specific presentations and slides containing your search terms. • Downloadable PDFs of presentation slides and syllabi summaries. • Downloadable MP3 files provide the option of listening to any (or all) lectures while driving, traveling, or any occasion where audio is most convenient. • A complimentary portable hard drive2 for offline viewing when internet is not available. 1
2
.
Specific presentations within a session may not be available or may be audio only if the presenter has confidential patient information or otherwise declines to be recorded. Hard drive does not include all the functionality available online, such as Advanced Search, MP3/PDF Downloads, Bookmarks, Recently Viewed and CME testing.
Order Annual Meeting On Demand by April 28 and save $1,150 or more off the regular price! All attendees will receive complimentary online access to Syllabi for one-year. Upgrade to a USB drive for permanent use. Annual Meeting On Demand
Syllabi On Demand (USB Upgrade)
LIST PRICE
$1,749
$299
MEMBER, SENIOR & HONORARY
$399 Save $1,350
$39 Save $260
NONMEMBER
$599 Save $1,150
$59 Save $240
JUNIOR & NON-NEUROLOGIST MEMBER
$199 Save $1,550
$29 Save $270
Order In Person: The Education & Publications Station located on Meeting Level 1 Order Online: AANonDemand.com/Boston Order by Phone: (800) 501-2303 (US only) or (818) 844-3299 Meeting discounts expire April 28, 2017.
What Are P Do you have any advice for any first-time attendees?
Take it all in and enjoy the interactions with the other physicians. Look at the posters—there’s a lot of great research out there. And enjoy yourself!
How does this meeting compare to previous ones? Ramona McCormick Nonmember Carmel, IN
Thomas N. Ward, MD, FAAN Neurologist Member Norwich, VT
It amazes me that the Academy is able to be as well-organized as it is considering how big the meeting is. I think a lot of the newer things like the app make it really easy to come here and find exactly what you want. The fact that you can pay one fee and attend just about everything is a major step forward they’ve had for the last couple of years. I really enjoy the meeting.
People Saying? Do you have any advice that you could give a first-time attendee?
Get here early and figure out where everything is. Looking at the schedule in advance and pinpointing and earmarking the sessions or posters that you really want to see also helps. The new app really helps a lot with that. I was able to use the calendar function and put things directly on my Kristina M. Reyes, PharmD calendar. So plan ahead. Researcher Member Santa Paula, CA
What is your impression of the meeting?
What is your impression of the meeting so far? Raymond A. Faber, MD It’s been Senior Member San Antonio, TX terrific, the way it’s now organized. The app is terrific. I’ve learned a lot.
Is there anything specific you came to learn?
Just to get to hear the current thinking in the areas that I’m most interested in in cognitive behavioral neurology and neuropsychiatry. They’ve had some excellent sessions.
Very, very good. I'm doing my PhD work and I have attended a lot of conferences—and this is the biggest and the best I have seen. It’s very organized and there are lots of very top-notch people to meet, a lot of things to talk about, and the work is wonderful, wonderful! It's a great event to be at and I'm planning to come next year and each year.
Zahra N. Rezvani, MD Junior Member Baltimore, MD
Is this your first Annual Meeting?
Johannes Pulst-Korenberg, MD Junior Member Philadelphia, PA
As a child, I went to a few. I was taken along because one of my family members is pretty involved in the Academy. My dad is Stefan Pulst. But this is the first time that I've had a more legitimate reason to be here and I'm actually presenting my first poster ever. It's on an HIV-associated motor neuron disease case that I saw that had really cool MRI findings.
Tuesday, April 25, 2017 • AANextra
29
Improve Your Patients’ Experience with Interactive Electronic Exam Room Posters The AAN has partnered with Health Monitor Network, a patient education company, to offer free electronic touchscreen posters for US members’ exam rooms.
Health Monitor Network has partnerships with other medical organizations, such as the American Gastroenterological Association, as well as patient advocacy groups.
The AAN will review content for the posters for medical accuracy.
To learn more about the electronic posters, visit Health Monitor Network in the Exhibit Hall at booth #127.
“The work group of physicians who tested out the electronic posters were impressed by the content,” said Bert B. Vargas, MD, FAAN, chair of the Digital Strategy Subcommittee. “They especially liked the graphics and felt they could be very useful as patient education tools. These posters could be an effective way to increase patient satisfaction and decrease their perceived wait time.”
Bert B. Vargas, MD, FAAN
Each poster features educational charts, diagrams, and tips on managing neurologic conditions. The 21.5” screen silently rotates panels every 25 seconds, with no interaction needed from health care professionals, office staff, or patients. Clear, engaging videos play only when activated, with a suite of controls, including an easy-to-find pause button. Installation of the posters is free, and they do not require WiFi. They plug into the wall, and any maintenance is conducted by Health Monitor Network. Content is updated quarterly. The posters are available for all member practices in the US, excluding Alaska, Hawaii, and Puerto Rico.
New to the Annual Meeting? Tomorrow’s Orientation Session Is for You! Get the most out of your first Annual Meeting experience at tomorrow’s Annual Meeting Orientation Session. This informative and interactive one-hour session is designed to highlight a basic overview of the Annual Meeting, including Programs and events going on throughout the week Information on networking opportunities Valuable AAN resources designed for all member types and career stages How to use the Annual Meeting Mobile App Tips on can’t-miss social and networking events
When: Wednesday, April 26 Time: 7:00 a.m.–8:00 a.m. Location: HeadTalks Experiential Learning Area Host: Maisha T. Robinson, MD, MS
TAKE A LOOK INSIDE
VISIT
BOOTH 591 To learn more, including details on our live reader training.
©Lilly USA, LLC 2017. All rights reserved. PP-AM-US-0166 03/2017. Amyvid™ is a trademark of Eli Lilly and Company.
VISIT US IN BOOTH #244
©2017 Biogen. All rights reserved. 03/17 TEC-US-2005