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. OʼBrien

Research output: Contribution to journalArticle

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

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Therapeutics
Safety
Tardive Dyskinesia
valbenazine
Abnormal Involuntary Movement Scale

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

Cite this

Marder, S. R., Singer, C., Lindenmayer, J. P., Tanner, C. M., Comella, C. L., Verghese, C., ... OʼBrien, 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

A Phase 3, 1-Year, Open-Label Trial of Valbenazine in Adults With Tardive Dyskinesia. / Marder, Stephen R.; Singer, Carlos; Lindenmayer, Jean Pierre; Tanner, Caroline M.; Comella, Cynthia L.; Verghese, Cherian; Jimenez, Roland; Liang, Grace S.; Burke, Joshua; OʼBrien, Christopher F.

In: Journal of clinical psychopharmacology, Vol. 39, No. 6, 01.11.2019, p. 620-627.

Research output: Contribution to journalArticle

Marder, SR, Singer, C, Lindenmayer, JP, Tanner, CM, Comella, CL, Verghese, C, Jimenez, R, Liang, GS, Burke, J & OʼBrien, CF 2019, 'A Phase 3, 1-Year, Open-Label Trial of Valbenazine in Adults With Tardive Dyskinesia', Journal of clinical psychopharmacology, vol. 39, no. 6, pp. 620-627. https://doi.org/10.1097/JCP.0000000000001111
Marder, Stephen R. ; Singer, Carlos ; Lindenmayer, Jean Pierre ; Tanner, Caroline M. ; Comella, Cynthia L. ; Verghese, Cherian ; Jimenez, Roland ; Liang, Grace S. ; Burke, Joshua ; OʼBrien, Christopher F. / A Phase 3, 1-Year, Open-Label Trial of Valbenazine in Adults With Tardive Dyskinesia. In: Journal of clinical psychopharmacology. 2019 ; Vol. 39, No. 6. pp. 620-627.
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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.",
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AU - Tanner, Caroline M.

AU - Comella, Cynthia L.

AU - Verghese, Cherian

AU - Jimenez, Roland

AU - Liang, Grace S.

AU - Burke, Joshua

AU - OʼBrien, Christopher F.

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N2 - 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.

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