Hostname: page-component-6b989bf9dc-mbg9n Total loading time: 0 Render date: 2024-04-13T20:50:05.753Z Has data issue: false hasContentIssue false

38 Global Improvement and Patient Satisfaction: Results from a Long-term, Open-label, Rollover Study of Valbenazine in Tardive Dyskinesia

Published online by Cambridge University Press:  12 March 2019

Cherian Verghese
Principal Investigator, Keystone Clinical Studies, LLC, Norristown, PA
Jean-Pierre Lindenmayer
Clinical Professor, Department of Psychiatry, New York University School of Medicine, New York, NY
Stephen R. Marder
Professor, Psychiatry and Biobehavioral Sciences, University of California Los Angeles, David Geffen School of Medicine, Los Angeles, CA
Joshua Burke
Director, Biostatistics and Data Management, Neurocrine Biosciences, Inc., San Diego, CA
Roland Jimenez
Director, Clinical Programs, Neurocrine Biosciences, Inc., San Diego, CA
Chuck Yonan
Senior Director, HEOR, Neurocrine Biosciences, Inc., San Diego, CA
Khody Farahmand
Director, Medical Communications, Neurocrine Biosciences, Inc., San Diego, CA
Scott Siegert
Executive Director, Medical Affairs, Neurocrine Biosciences, Inc., San Diego, CA
Rights & Permissions [Opens in a new window]


Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.

Valbenazine (VBZ) is a novel vesicular monoamine transporter 2 (VMAT2) inhibitor approved to treat tardive dyskinesia (TD) in adults. It has been evaluated in 2 long-term studies (KINECT 3, KINECT 4) in which participants received VBZ (40 or 80mg) for up to 48weeks. This long-term rollover study (NCT02736955) was conducted to evaluate global TD improvement and patient satisfaction with once-daily VBZ.


Key eligibility criteria: age 18 to 85 years; completion of KINECT 3 or KINECT 4; maintenance medications (for schizophrenia, schizoaffective disorder, or mood disorder) at stable doses; Brief Psychiatric Rating Scale score <50; no significant risk of active suicidal ideation or behavior. Following washout of prior VBZ treatment (Weeks 48 to 52 of KINECT 3 and KINECT 4), participants were re-initiated at 40mg (4weeks) and escalated to 80mg based on tolerability and clinical assessment of TD; dose was reduced to 40mg if 80mg was not tolerated (80/40mg). If unable to tolerate the 40mg dose, the participant was discontinued. Participants received open-label VBZ for up to 72weeks or until commercial availability. Assessments included Clinical Global Impression of Severity-TD (CGIS-TD: range, 1[“normal, not at all ill”] to 7[“among the most extremely ill patient”]) and Patient Satisfaction Questionnaire (PSQ: range, 1[“very satisfied”] to 5[“very dissatisfied”]).


160 participants with available data were included in analyses (40mg =35; 80mg =117; 80/40mg =8); 138 were receiving treatment when VBZ became commercially available. The percentages of participants who completed visits at Wks 12, 24, 36, and 48 were 96.3%, 78.1%, 56.9% and 35.0%, respectively. Few reached Wk 60 (n=4) or Wk 72 (n=0) due to commercial availability. The percentage of participants with CGIS-TD score ≤2 (“normal, not at all ill” or “borderline ill”) increased from baseline (before restarting VBZ) (40mg, 5.7%; 80mg, 18.1%) to Wk 48 (40mg , 41.7%; 80mg , 74.4%). At baseline, almost all participants rated their prior VBZ experience with a PSQ score ≤2 (“very satisfied” or “somewhat satisfied”) (40mg , 100%, 80mg , 99.1%). Similar results were seen at the Wk 48 visit, with most participants continuing to express satisfaction with VBZ (40mg , 100%; 80mg , 97.4%).


A clinician-based global assessment indicated ongoing, meaningful TD improvements in adults who received once-daily VBZ in the current study. In participants treated for >1 year, continued patient satisfaction rates with VBZ were high.

Funding Acknowledgements: Neurocrine Biosciences, Inc.

© Cambridge University Press 2019