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A Phase 3, 1-Year, Open-Label Trial of Valbenazine in Adults With Tardive Dyskinesia.
J Clin Psychopharmacol. 2019 Nov/Dec; 39(6):620-627.JC

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.

Authors+Show Affiliations

From the Department of Psychiatry and Behavioral Sciences, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA.Department of Neurology, Leonard M. Miller School of Medicine, University of Miami, Miami, FL.Department of Psychiatry, New York University School of Medicine, New York, NY.Department of Neurology, University of California, San Francisco, and San Francisco Veterans Affairs Health Care System, San Francisco, CA.Department of Neurosurgery and Neurological Sciences, Rush University Medical Center, Chicago, IL.Keystone Clinical Studies, LLC, Norristown, PA.Neurocrine Biosciences, Inc., San Diego, CA.Neurocrine Biosciences, Inc., San Diego, CA.Neurocrine Biosciences, Inc., San Diego, CA.Neurocrine Biosciences, Inc., San Diego, CA.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

31688452

Citation

Marder, Stephen R., et al. "A Phase 3, 1-Year, Open-Label Trial of Valbenazine in Adults With Tardive Dyskinesia." Journal of Clinical Psychopharmacology, vol. 39, no. 6, 2019, pp. 620-627.
Marder SR, Singer C, Lindenmayer JP, et al. A Phase 3, 1-Year, Open-Label Trial of Valbenazine in Adults With Tardive Dyskinesia. J Clin Psychopharmacol. 2019;39(6):620-627.
Marder, S. R., Singer, C., Lindenmayer, J. P., Tanner, C. M., Comella, C. L., Verghese, C., Jimenez, R., Liang, G. S., Burke, J., & 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
Marder SR, et al. A Phase 3, 1-Year, Open-Label Trial of Valbenazine in Adults With Tardive Dyskinesia. J Clin Psychopharmacol. 2019 Nov/Dec;39(6):620-627. PubMed PMID: 31688452.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A Phase 3, 1-Year, Open-Label Trial of Valbenazine in Adults With Tardive Dyskinesia. AU - Marder,Stephen R, AU - Singer,Carlos, AU - Lindenmayer,Jean-Pierre, 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, PY - 2019/11/7/pubmed PY - 2020/4/21/medline PY - 2019/11/6/entrez SP - 620 EP - 627 JF - Journal of clinical psychopharmacology JO - J Clin Psychopharmacol VL - 39 IS - 6 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. SN - 1533-712X UR - https://www.unboundmedicine.com/medline/citation/31688452/A_Phase_3_1_Year_Open_Label_Trial_of_Valbenazine_in_Adults_With_Tardive_Dyskinesia_ L2 - https://doi.org/10.1097/JCP.0000000000001111 DB - PRIME DP - Unbound Medicine ER -