A Phase 3, 1-Year, Open-Label Trial of Valbenazine in Adults With Tardive Dyskinesia

Stephen R. Marder, Carlos Singer, Jean Pierre Lindenmayer, Caroline M. Tanner, Cynthia L. Comella, Cherian Verghese, Roland Jimenez, Grace S. Liang, Joshua Burke, Christopher F. O'brien

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

Purpose/Background Valbenazine is approved to treat tardive dyskinesia (TD) in adults. KINECT 4 (NCT02405091) was conducted to explore the long-term effects of once-daily valbenazine in patients with TD. Methods/Procedures The study included a 48-week, open-label treatment period and 4-week washout. Dosing was initiated at 40 mg/d, with escalation to 80 mg/d at week 4 based on efficacy and tolerability. Standard safety methods were applied, including treatment-emergent adverse event (TEAE) reporting. Valbenazine effects on TD were assessed using the Abnormal Involuntary Movement Scale (AIMS), Clinical Global Impression of Change-TD, and Patient Global Impression of Change. Findings/Results After week 4, <15% of all participants had a serious TEAE (13.7%) or TEAE leading to discontinuation (11.8%). Participants experienced TD improvements during long-term treatment as indicated by mean change from baseline to week 48 in AIMS total score (sum of items 1-7, evaluated by site raters) with valbenazine 40 mg/d (-10.2 [n = 45]) or 80 mg/d (-11.0 [n = 107]). At week 48, most participants had ≥50% improvement from baseline in AIMS total score (40 mg/d, 90.0%; 80 mg/d, 89.2%), Clinical Global Impression of Change-TD rating of much or very much improved (40 mg/d, 90.0%; 80 mg/d, 95.9%), and Patient Global Impression of Change rating of much or very much improved (40 mg/d, 90.0%; 80 mg/d, 89.2%). No dose effects were apparent by week 36. Week 52 results indicated some loss of effect after washout. Implications/Conclusions Valbenazine was generally well tolerated, and no new safety concerns were detected. Substantial clinician- and patient-reported improvements were observed in adults with TD who received once-daily valbenazine for up to 48 weeks.

Original languageEnglish (US)
Pages (from-to)620-627
Number of pages8
JournalJournal of clinical psychopharmacology
Volume39
Issue number6
DOIs
StatePublished - Nov 1 2019

Keywords

  • long-term
  • open-label
  • safety
  • tardive dyskinesia
  • valbenazine

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

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    Marder, S. R., Singer, C., Lindenmayer, J. P., Tanner, C. M., Comella, C. L., Verghese, C., Jimenez, R., Liang, G. S., Burke, J., & O'brien, C. F. (2019). A Phase 3, 1-Year, Open-Label Trial of Valbenazine in Adults With Tardive Dyskinesia. Journal of clinical psychopharmacology, 39(6), 620-627. https://doi.org/10.1097/JCP.0000000000001111