Skip to main content
Advertisement
  • Neurology.org
  • Journals
    • Neurology
    • Clinical Practice
    • Education
    • Genetics
    • Neuroimmunology & Neuroinflammation
  • Online Sections
    • Neurology Video Journal Club
    • Diversity, Equity, & Inclusion (DEI)
    • Neurology: Clinical Practice Accelerator
    • Practice Buzz
    • Practice Current
    • Residents & Fellows
    • Without Borders
  • Collections
    • COVID-19
    • Disputes & Debates
    • Health Disparities
    • Infographics
    • Neurology Future Forecasting Series
    • Null Hypothesis
    • Patient Pages
    • Topics A-Z
    • Translations
    • UDDA Revision Series
  • Podcast
  • CME
  • About
    • About the Journals
    • Contact Us
    • Editorial Board
  • Authors
    • Submit Manuscript
    • Author Center

Advanced Search

Main menu

  • Neurology.org
  • Journals
    • Neurology
    • Clinical Practice
    • Education
    • Genetics
    • Neuroimmunology & Neuroinflammation
  • Online Sections
    • Neurology Video Journal Club
    • Diversity, Equity, & Inclusion (DEI)
    • Neurology: Clinical Practice Accelerator
    • Practice Buzz
    • Practice Current
    • Residents & Fellows
    • Without Borders
  • Collections
    • COVID-19
    • Disputes & Debates
    • Health Disparities
    • Infographics
    • Neurology Future Forecasting Series
    • Null Hypothesis
    • Patient Pages
    • Topics A-Z
    • Translations
    • UDDA Revision Series
  • Podcast
  • CME
  • About
    • About the Journals
    • Contact Us
    • Editorial Board
  • Authors
    • Submit Manuscript
    • Author Center
  • Home
  • Latest Articles
  • Current Issue
  • Past Issues
  • Neurology Video Journal Club
  • Residents & Fellows

User menu

  • Subscribe
  • My Alerts
  • Log in

Search

  • Advanced search
Neurology
Home
The most widely read and highly cited peer-reviewed neurology journal
  • Subscribe
  • My Alerts
  • Log in
Site Logo
  • Home
  • Latest Articles
  • Current Issue
  • Past Issues
  • Neurology Video Journal Club
  • Residents & Fellows

Share

April 18, 2017; 88 (16 Supplement) April 28, 2017

Efficacy of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia: Results of a Long-Term Study (KINECT 3 Extension) (S56.005)

Stewart Factor, Cynthia Comella, Christoph Correll, Grace Liang, Joshua Burke, Christopher O’Brien
First published April 17, 2017,
Stewart Factor
1Emory University School of Medicine Atlanta GA United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Cynthia Comella
2Rush University Medical Center Chicago IL United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Christoph Correll
3Hofstra Northwell School of Medicine New York NY United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Grace Liang
4Neurocrine Biosciences, Inc. San Diego CA United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Joshua Burke
4Neurocrine Biosciences, Inc. San Diego CA United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Christopher O’Brien
4Neurocrine Biosciences, Inc. San Diego CA United States
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Citation
Efficacy of Valbenazine (NBI-98854) in Subjects with Tardive Dyskinesia: Results of a Long-Term Study (KINECT 3 Extension) (S56.005)
Stewart Factor, Cynthia Comella, Christoph Correll, Grace Liang, Joshua Burke, Christopher O’Brien
Neurology Apr 2017, 88 (16 Supplement) S56.005;

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero
Permissions

Make Comment

See Comments

Downloads
0

Share

  • Article
  • Info & Disclosures
Loading

Abstract

Objective: To assess the long-term efficacy of valbenazine (NBI-98854) in treating tardive dyskinesia (TD).

Background: Valbenazine is a novel, highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor in development for TD treatment. The efficacy and safety of valbenazine have been demonstrated in double-blind, placebo-controlled (DBPC) trials, with significant improvements found in Abnormal Involuntary Movement Scale (AIMS) dyskinesia total score (items 1–7) and Clinical Global Impression of Change (CGI-TD) score.

Design/Methods: KINECT 3 (phase 3 trial) included a 6-week DBPC period, 42-week valbenazine extension (VE) period, and 4-week treatment-free follow-up. Adults with TD and schizophrenia/schizoaffective disorder or mood disorder were enrolled; stable concomitant antipsychotic medication regimens were allowed. Subjects completing the DBPC period were eligible for the VE period. Those initially randomized to placebo were re-randomized to valbenazine 80 or 40 mg/day; those randomized to valbenazine continued on same doses. Efficacy assessments included the AIMS (mean score changes, responders) and CGI-TD (mean scores, responders).

Results: 198 subjects entered the VE period; 124 completed treatment (80mg/day, n=63; 40mg/day, n=61) and 121 completed follow-up. At Week 48, AIMS results indicated TD improvement in both valbenazine dose groups: mean score changes (80mg/day, −4.8; 40mg/day, −3.0); responders (percent of subjects with ≥50% AIMS score reduction; 80mg/day, 52%; 40mg/day, 28%). However, AIMS scores increased from Week 48 to Week 52 (80mg/day, 6.2 to 9.8; 40mg/day, 6.8 to 8.4), indicating worsening of TD during the 4-week no-treatment period. Mean Week 48 CGI-TD scores demonstrated clinically meaningful global improvements (80mg/day, 2.1; 40mg/day, 2.4) with 76% and 59% of subjects (80mg/day and 40mg/day, respectively) rated as “much improved” or “very much improved.”

Conclusions: TD improved in subjects receiving valbenazine for 48 weeks, with TD reappearing after medication was withdrawn. Together with the long-term safety profile (presented separately), these results indicate that long-term valbenazine may be beneficial for managing TD.

Study Supported by: Neurocrine Biosciences, Inc.

Disclosure: Dr. Factor has received personal compensation for activities with Lundbeck, TEVA, Neurocrine, Avanir, Cynapsus, and Adamas as a consultant and from Uptodate as a speaker. Dr. Factor has received research support from Ipsen, Auspex/Teva, US World Meds, Pharm-Olam, Cynapsus Therapeutics, Solstice, CHDI Foundation, Michael J. Fox Foundation, NIH and Medtronic. Dr. Comella has received personal compensation for activities with Ipsen, Merz, Allergan, Medtronic, Teva, US World Meds, Impax, Acadia, Acorda, Revance, Neurocrine, Ultragenx Pharmaceuticals as a consultant. Dr. Correll has received personal compensation for activities with Alkermes, Allergan, Forum, Gerson Lehrman Group, IntraCellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, Medavante, Medscape, Neurocrine, Otsuka as a consultant, advisor or speaker. Dr. Liang has received personal compensation from Neurocrine Biosciences, Inc. Dr. Burke has received personal compensation for activities with Neurocrine Biosciences, Inc. as an employee. Dr. O'Brien has received personal compensation for activities with Neurocrine Biosciences, Inc.

Letters: Rapid online correspondence

No comments have been published for this article.
Comment

REQUIREMENTS

You must ensure that your Disclosures have been updated within the previous six months. Please go to our Submission Site to add or update your Disclosure information.

Your co-authors must send a completed Publishing Agreement Form to Neurology Staff (not necessary for the lead/corresponding author as the form below will suffice) before you upload your comment.

If you are responding to a comment that was written about an article you originally authored:
You (and co-authors) do not need to fill out forms or check disclosures as author forms are still valid
and apply to letter.

Submission specifications:

  • Submissions must be < 200 words with < 5 references. Reference 1 must be the article on which you are commenting.
  • Submissions should not have more than 5 authors. (Exception: original author replies can include all original authors of the article)
  • Submit only on articles published within 6 months of issue date.
  • Do not be redundant. Read any comments already posted on the article prior to submission.
  • Submitted comments are subject to editing and editor review prior to posting.

More guidelines and information on Disputes & Debates

Compose Comment

More information about text formats

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Author Information
NOTE: The first author must also be the corresponding author of the comment.
First or given name, e.g. 'Peter'.
Your last, or family, name, e.g. 'MacMoody'.
Your email address, e.g. [email protected]
Your role and/or occupation, e.g. 'Orthopedic Surgeon'.
Your organization or institution (if applicable), e.g. 'Royal Free Hospital'.
Publishing Agreement
NOTE: All authors, besides the first/corresponding author, must complete a separate Publishing Agreement Form and provide via email to the editorial office before comments can be posted.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Vertical Tabs

You May Also be Interested in

Back to top
  • Article
  • Info & Disclosures
Advertisement

Hastening the Diagnosis of Amyotrophic Lateral Sclerosis

Dr. Brian Callaghan and Dr. Kellen Quigg

► Watch

Related Articles

  • No related articles found.

Alert Me

  • Alert me when eletters are published
Neurology: 101 (22)

Articles

  • Ahead of Print
  • Current Issue
  • Past Issues
  • Popular Articles
  • Translations

About

  • About the Journals
  • Ethics Policies
  • Editors & Editorial Board
  • Contact Us
  • Advertise

Submit

  • Author Center
  • Submit a Manuscript
  • Information for Reviewers
  • AAN Guidelines
  • Permissions

Subscribers

  • Subscribe
  • Activate a Subscription
  • Sign up for eAlerts
  • RSS Feed
Site Logo
  • Visit neurology Template on Facebook
  • Follow neurology Template on Twitter
  • Visit Neurology on YouTube
  • Neurology
  • Neurology: Clinical Practice
  • Neurology: Education
  • Neurology: Genetics
  • Neurology: Neuroimmunology & Neuroinflammation
  • AAN.com
  • Continuum
  • Brain & Life
  • Neurology Today

Wolters Kluwer Logo

Neurology | Print ISSN:0028-3878
Online ISSN:1526-632X

© 2023 American Academy of Neurology

  • Privacy Policy
  • Feedback
  • Advertise