Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia

Hubert H. Fernandez*, David Stamler, Mat D. Davis, Stewart A. Factor, Robert A. Hauser, Joohi Jimenez-Shahed, William G. Ondo, L. Fredrik Jarskog, Scott W. Woods, Danny Bega, Mark S. Ledoux, David R. Shprecher, Karen E. Anderson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

Objective To evaluate the long-term safety and efficacy of deutetrabenazine in patients with tardive dyskinesia (TD). Method Patients with TD who completed the 12 week, phase 3, placebo-controlled trials were eligible to enter this open-label, single-arm study. The open-label study consisted of a 6 week dose-escalation phase and a long-term maintenance phase (clinic visits at Weeks 4, 6 and 15, and every 13 weeks until Week 106). Patients began deutetrabenazine at 12 mg/day, titrating up to a dose that was tolerable and provided adequate dyskinesia control, based on investigator judgement, with a maximum allowed dose of 48 mg/day (36 mg/day for patients taking strong cytochrome P450 2D6 (CYP2D6) inhibitors). Safety measures included incidence of adverse events (AEs) and scales used to monitor parkinsonism, akathisia/restlessness, anxiety, depression, suicidality and somnolence/sedation. Efficacy endpoints included the change in Abnormal Involuntary Movement Scale (AIMS) score (items 1 to 7) from baseline and the proportion of patients rated as 'Much Improved' or 'Very Much Improved' on the Clinical Global Impression of Change. Results A total of 343 patients enrolled in the extension study, and there were 331 patient-years of exposure in this analysis. The exposure-adjusted incidence rates of AEs with long-term treatment were comparable to or lower than those observed in the phase 3 trials. The mean (SE) change in AIMS score was -4.9 (0.4) at Week 54 (n = 146), - 6.3 (0.7) at Week 80 (n = 66) and -5.1 (2.0) at Week 106 (n = 8). Conclusions Overall, long-term treatment with deutetrabenazine was efficacious, safe, and well tolerated in patients with TD. Trial registration number NCT02198794.

Original languageEnglish (US)
Pages (from-to)1317-1323
Number of pages7
JournalJournal of Neurology, Neurosurgery and Psychiatry
Volume90
Issue number12
DOIs
StatePublished - Dec 1 2019

Keywords

  • deutetrabenazine
  • movement disorders
  • tardive dyskinesia
  • vmat2 inhibitor

ASJC Scopus subject areas

  • Surgery
  • Clinical Neurology
  • Psychiatry and Mental health

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