Session Information
Date: Tuesday, June 6, 2017
Session Title: Huntington's Disease
Session Time: 1:45pm-3:15pm
Location: Exhibit Hall C
Objective: To evaluate the safety and tolerability of deutetrabenazine in Huntington Disease (HD) over long term exposure.
Background: In a randomized, double-blind, controlled trial (First-HD), 12-weeks treatment with deutetrabenazine (DTB) reduced total maximal chorea (TMC) score by 4.4 units versus 1.9 units in placebo (ref). A one week washout followed treatment. Since HD is a chronic, progressive neurological disorder, this subsequent study evaluated the long term safety and efficacy of deutetrabenazine exposure.
Methods: Two cohorts were included in this open-label study: subjects who completed First-HD, including a one-week washout (Rollover cohort, n=87); and subjects who converted overnight from a stable dose of tetrabenazine (Switch cohort, n=37). Patients who completed First-HD were individually titrated to a dose that reduced chorea and was well-tolerated. Switch subjects were converted from tetrabenazine to a predicted comparable dose of DTB after Baseline Visit Safety was assessed every three months in the combined open label patient group. Due to varying lengths of treatment, exposure-adjusted incidence rates (EAIR; adverse events (AEs) per person-year) were calculated.
Results: 119 patients were enrolled and 99 subjects completed at least one year of DTB treatment. The EAIR of subjects reporting any AE, serious AEs and AEs leading to withdrawal was similar between the Rollover and Switch cohorts. The most common AEs were fall, somnolence and depression. At week 54, TMC was reduced by 4.1 and 3.0 units in the Rollover and Switch cohorts, respectively.
Conclusions: Overall, the adverse event profile of with long term deutetrabenazine treatment is consistent with that reported in First-HD. Rollover patients from First-HD were able to achieve a similar reduction in chorea as observed in First-HD. Patients who switched from TBZ to DTB were able to achieve improved chorea control.
References: Huntington Study Group. Effect of Deutetrabenazine on Chorea Among Patients With Huntington Disease. JAMA. 2016;316(1):40-50.
To cite this abstract in AMA style:
S. Frank, C. Vaughan, D. Stamler, D. Oakes, M. Davis, S. Eberly, E. Kayson, J. Whaley, J. Goldstein, C. Testa. The Long-Term Safety of Deutetrabenazine for Chorea in Huntington Disease [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/the-long-term-safety-of-deutetrabenazine-for-chorea-in-huntington-disease/. Accessed June 14, 2025.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/the-long-term-safety-of-deutetrabenazine-for-chorea-in-huntington-disease/