A Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 211
- 主要终点
- Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM)
研究概览
简要总结
The purpose of this study is to determine whether fixed-doses of an investigational drug, SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of tardive dyskinesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of using a dopamine receptor antagonist for at least 3 months
- •Clinical diagnosis of tardive dyskinesia and has had symptoms for at least 3 months prior to screening
- •Subjects with underlying psychiatric diagnosis are stable and have no change in psychoactive medications
- •Have a mental health provider and does not anticipate any changes to treatment regimen in the next 3 months
- •History of being compliant with prescribed medications
- •Able to swallow study drug whole
- •Be in good general health and is expected to attend all study visits and complete study assessments
- •Female subjects must not be pregnant and must agree to an acceptable method of contraception throughout the study
排除标准
- •Currently receiving medication for the treatment of tardive dyskinesia
- •Have a neurological condition other than tardive dyskinesia that may interfere with assessing the severity of dyskinesias
- •Have a serious untreated or undertreated psychiatric illness
- •Have recent history or presence of violent behavior
- •Have unstable or serious medical illness
- •Have evidence of hepatic impairment
- •Have evidence of renal impairment
- •Have known allergy to any component of SD-809 or tetrabenazine
- •Has participated in an investigational drug or device trial and received study drug or device within 30 days
- •Have acknowledged use of illicit drugs
- •Have a history of alcohol or substance abuse in the previous 12 months
研究组 & 干预措施
SD-809 36 mg/day
SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 18 mg BID. The total daily dose of 36 mg was maintained for an additional 8 weeks.
干预措施: SD-809 (Drug)
Placebo
Placebo tablets taken twice daily for 12 weeks.
干预措施: Placebo (Drug)
SD-809 12 mg/day
SD-809 tablets 6 mg taken twice a day (BID) for 12 weeks.
干预措施: SD-809 (Drug)
SD-809 24 mg/day
SD-809 tablets dose starting at 6 mg twice a day (BID) and titrated over 4 weeks to 12 mg BID. The total daily dose of 24 mg was maintained for an additional 8 weeks.
干预措施: SD-809 (Drug)
结局指标
主要结局
Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model For Repeated Measures (MMRM)
时间窗: Day 0 (Baseline), Weeks 2, 4, 8 and 12
AIMS is an assessment tool used to detect and follow the severity of tardive dyskinesia (TD) over time. AIMS is composed of 12 clinician-administered and scored items. The exam was digitally video recorded using a standard protocol, and independently reviewed by blinded central raters who were experts in movement disorders. This outcome sums items 1 through 7 which cover orofacial movements, as well as extremity and truncal dyskinesia (the total motor AIMS score). Ratings were based on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe) for a total scale of 0-28. A negative change from baseline score indicates improvement. MMRM with treatment group, visit, treatment group-by-visit interaction, and baseline use of dopamine receptor antagonist (DRAs) as fixed effects and the baseline value as a covariate. The model was fit using an unstructured covariance structure.
次要结局
- Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)(Week 12)
- Change in the Modified Craniocervical Dystonia Questionnaire (mCDQ-24) Total Score From Baseline to Week 12(Day 0 (Baseline), Week 12)
- Percentage of Patients Considered a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)(Week 12)
- Percentage of Participants Who Had a 50% or Greater Reduction in Total Motor Abnormal Involuntary Movement Scale (AIMS) From Baseline to Week 12(Day 0 (Baseline), Week 12)
- Percent Change in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using a Mixed Model for Repeated Measures (MMRM)(Day 0 (Baseline), Weeks 2, 4, 8 and 12)
- Cumulative Percentage of Responders Based on Change in in Total Motor Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Recorded in Incremental Steps of 10 Percentage Points(Day 0 (Baseline), Week 12)
- Participants With Adverse Events During the Overall Treatment Period(Day 1 to Week 12)