About Clinical Trial of Huntington's disease (HD)
The efficacy of AUSTEDO® as a treatment for chorea associated with Huntington's disease was established in a randomized, double-blind, placebo-controlled, multi-center trial conducted in 90 ambulatory patients with manifest chorea associated with Huntington’s disease, the main clinical evaluation index was Total Maximal Chorea (TMC) Scores of HD. The research results showed that AUSTEDO®:
- Had a significant treatment effect: TMC score for patients receiving AUSTEDO® improved by approximately 4.4 units from baseline to the maintenance period (compared to 1.9 units in the placebo group, P<0.001). 33% of patients increased TMC score by at least 6 units (compared to 2% of patients in the placebo group). According to Unified Huntington Disease Rating Scale (UHDRS), the average improvement for patients receiving AUSTEDO® was 7.4 units (compared to 3.4 units in the placebo group, P=0.002).
- Significantly improved the treatment success rate: According to Patient Global Impression of Change (PGIC), the success rate for patients receiving AUSTEDO® was 51% (compared to 20% in the placebo group, P=0.002). According to Clinical Global Impression of Change (CGIC), the success rate for patients receiving AUSTEDO® was 42% (compared to 13% in the placebo group, P=0.002).
- Has a favorable safety profile, with low rates of neuropsychiatric events in patients starting therapy.
- 具有显著的治疗效果：治疗第12周氘代丁苯那嗪组的异常不自主运动量（Abnormal Involuntary Movement Scale，AIMS）评分改善幅度为3.3（安慰剂组1.5，P<0.001），AIMS评分提升50%以上的患者比例为33%（安慰剂组12%，P=0.007）。
About Clinical Trial of Tardive Dyskinesia (TD) in Adults9
The approval was based on results from two Phase III randomized, double-blind, placebo-controlled, parallel group studies, which proved that AUSTEDO®:
- Has a significant treatment effect: Abnormal Involuntary Movement Scale (AIMS) score for patients receiving AUSTEDO® improved by 3.3 units in the week 12 (compared to 1.5 units in the placebo group, P<0.001). 33% of patients increased AIMS score by 50% (compared to 12% of patients in the placebo group, P=0.007).
- Improved the treatment success rate: In a pooled analysis of the ARM-TD and AIM-TD studies, the odds of treatment success in patients treated with deutetrabenazine were more than double the odds in those given placebo (2.1; P=0.005), and mean CGIC score was higher in deutetrabenazine-treated patients (48%) compared with placebo (30%) at Week 12.
- Has a favorable safety profile and is well tolerated. Deutetrabenazine does not adverselyimpact measures of somnolence, weight, or cardiometabolic factors.