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The Effects of Valbenazine in Participants with Tardive Dyskinesia: Results of the 1-Year KINECT 3 Extension Study.
J Clin Psychiatry. 2017 Nov/Dec; 78(9):1344-1350.JC

Abstract

BACKGROUND

Valbenazine, a highly selective vesicular monoamine transporter 2 inhibitor, is approved for the treatment of tardive dyskinesia. This is the first report of long-term effects in adults with tardive dyskinesia.

METHODS

Participants with a DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or a mood disorder who completed the 6-week, double-blind, placebo-controlled period of KINECT 3 were eligible to enter the 42-week valbenazine extension (VE) period and subsequent 4-week washout period. The extension phase was conducted from December 16, 2014, to August 3, 2016. Participants who received placebo and entered the VE period were re-randomized 1:1 to valbenazine 80 or 40 mg while others continued valbenazine at the KINECT 3 dose. Safety assessments included treatment-emergent adverse events (TEAEs) and scales for suicidal ideation/behavior, treatment-emergent akathisia or parkinsonism, and psychiatric symptoms. Efficacy assessments included the Abnormal Involuntary Movement Scale (AIMS) and Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD).

RESULTS

198 participants entered the VE period, 124 (62.6%) completed treatment (week 48), and 121 (61.1%) completed the follow-up visit after washout (week 52). During the VE period, 69.2% of participants had ≥ 1 TEAE, 14.6% had a serious TEAE, and 15.7% discontinued due to a TEAE. During washout, 13.1% of participants experienced a TEAE. No apparent risk for suicidal ideation or behavior was found. Long-term valbenazine treatment did not appear to induce or worsen akathisia or parkinsonism. Participants generally remained psychiatrically stable during the study. AIMS and CGI-TD measures indicated sustained tardive dyskinesia improvement, with scores returning toward baseline after 4 weeks of valbenazine washout.

CONCLUSIONS

The long-term safety and tolerability of valbenazine were generally favorable, and maintenance of treatment effect was apparent with both doses during this long-term study.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02274558.

Authors+Show Affiliations

Emory University School of Medicine, Department of Neurology, 12 Executive Park Dr NE, Room 284, Atlanta, GA 30329. sfactor@emory.edu. Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.Schizophrenia Division, Centre for Addiction and Mental Health, Toronto, Ontario, Canada.Department of Neurological Sciences, Rush University Medical Center, Chicago, Illinois, USA.Department of Psychiatry and Molecular Medicine, Hofstra Northwell School of Medicine, New York, New York, USA.Neurocrine Biosciences, Inc, San Diego, California, USA.Neurocrine Biosciences, Inc, San Diego, California, USA.Neurocrine Biosciences, Inc, San Diego, California, USA.Neurocrine Biosciences, Inc, San Diego, California, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

29141124

Citation

Factor, Stewart A., et al. "The Effects of Valbenazine in Participants With Tardive Dyskinesia: Results of the 1-Year KINECT 3 Extension Study." The Journal of Clinical Psychiatry, vol. 78, no. 9, 2017, pp. 1344-1350.
Factor SA, Remington G, Comella CL, et al. The Effects of Valbenazine in Participants with Tardive Dyskinesia: Results of the 1-Year KINECT 3 Extension Study. J Clin Psychiatry. 2017;78(9):1344-1350.
Factor, S. A., Remington, G., Comella, C. L., Correll, C. U., Burke, J., Jimenez, R., Liang, G. S., & O'Brien, C. F. (2017). The Effects of Valbenazine in Participants with Tardive Dyskinesia: Results of the 1-Year KINECT 3 Extension Study. The Journal of Clinical Psychiatry, 78(9), 1344-1350. https://doi.org/10.4088/JCP.17m11777
Factor SA, et al. The Effects of Valbenazine in Participants With Tardive Dyskinesia: Results of the 1-Year KINECT 3 Extension Study. J Clin Psychiatry. 2017 Nov/Dec;78(9):1344-1350. PubMed PMID: 29141124.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Effects of Valbenazine in Participants with Tardive Dyskinesia: Results of the 1-Year KINECT 3 Extension Study. AU - Factor,Stewart A, AU - Remington,Gary, AU - Comella,Cynthia L, AU - Correll,Christoph U, AU - Burke,Joshua, AU - Jimenez,Roland, AU - Liang,Grace S, AU - O'Brien,Christopher F, PY - 2017/06/30/received PY - 2017/10/11/accepted PY - 2017/11/16/pubmed PY - 2019/4/4/medline PY - 2017/11/16/entrez SP - 1344 EP - 1350 JF - The Journal of clinical psychiatry JO - J Clin Psychiatry VL - 78 IS - 9 N2 - BACKGROUND: Valbenazine, a highly selective vesicular monoamine transporter 2 inhibitor, is approved for the treatment of tardive dyskinesia. This is the first report of long-term effects in adults with tardive dyskinesia. METHODS: Participants with a DSM-IV diagnosis of schizophrenia, schizoaffective disorder, or a mood disorder who completed the 6-week, double-blind, placebo-controlled period of KINECT 3 were eligible to enter the 42-week valbenazine extension (VE) period and subsequent 4-week washout period. The extension phase was conducted from December 16, 2014, to August 3, 2016. Participants who received placebo and entered the VE period were re-randomized 1:1 to valbenazine 80 or 40 mg while others continued valbenazine at the KINECT 3 dose. Safety assessments included treatment-emergent adverse events (TEAEs) and scales for suicidal ideation/behavior, treatment-emergent akathisia or parkinsonism, and psychiatric symptoms. Efficacy assessments included the Abnormal Involuntary Movement Scale (AIMS) and Clinical Global Impression of Change-Tardive Dyskinesia (CGI-TD). RESULTS: 198 participants entered the VE period, 124 (62.6%) completed treatment (week 48), and 121 (61.1%) completed the follow-up visit after washout (week 52). During the VE period, 69.2% of participants had ≥ 1 TEAE, 14.6% had a serious TEAE, and 15.7% discontinued due to a TEAE. During washout, 13.1% of participants experienced a TEAE. No apparent risk for suicidal ideation or behavior was found. Long-term valbenazine treatment did not appear to induce or worsen akathisia or parkinsonism. Participants generally remained psychiatrically stable during the study. AIMS and CGI-TD measures indicated sustained tardive dyskinesia improvement, with scores returning toward baseline after 4 weeks of valbenazine washout. CONCLUSIONS: The long-term safety and tolerability of valbenazine were generally favorable, and maintenance of treatment effect was apparent with both doses during this long-term study. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02274558. SN - 1555-2101 UR - https://www.unboundmedicine.com/medline/citation/29141124/The_Effects_of_Valbenazine_in_Participants_with_Tardive_Dyskinesia:_Results_of_the_1_Year_KINECT_3_Extension_Study_ L2 - http://www.psychiatrist.com/JCP/article/Pages/2017/v78n09/17m11777.aspx DB - PRIME DP - Unbound Medicine ER -