A Randomized, Double-Blind, Placebo-Controlled Study of SD-809 (Deutetrabenazine) for the Treatment of Moderate to Severe Tardive Dyskinesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 主要终点
- Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis
研究概览
简要总结
The purpose of this study is to determine whether 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 75 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 agree to an acceptable method of contraception
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 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
SD-809 tablets taken twice daily for 12 weeks.
干预措施: SD-809 (Drug)
Sugar Pill
Placebo tablets taken twice daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using Mixed Model Repeated Measures (MMRM) Analysis
时间窗: Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12
AIMS is an assessment tool used to detect and follow the severity of TD over time. The AIMS is composed of 12 clinician-administered and scored items. AIMS 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, and extremity and truncal dyskinesia. Severity ratings were from 0 (none) to 4 (severe) for a total scale of 0 (no orofacial, truncal, and extremity dyskinesia) to 28 (severe orofacial, truncal, and extremity dyskinesia). A negative change from baseline score indicates improvement. A MMRM analysis with change from baseline in AIMS score as dependent variable was used. The model included fixed effects for treatment, time point, treatment-by-time point interaction, DRA status, and baseline AIMS as a covariate. An unstructured covariance model was used.
次要结局
- Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Clinical Global Impression of Change (CGIC)(Week 12)
- Percentage of Patients Who Are a Treatment Success at Week 12 as Assessed by the Patient Global Impression of Change (PGIC)(Week 12)
- Change From Baseline to Week 12 in the Modified Craniocervical Dystonia Questionnaire (CDQ-24)(Day 0 (Baseline), Week 12 with last observation carried forward)
- Change in Locally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis(Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12)
- Percentage Change in Centrally Read Abnormal Involuntary Movement Scale (AIMS) Score From Baseline to Week 12 Using MMRM Analysis(Day 0 (Baseline), Weeks 2, 4, 6, 9 and 12)
- Participants With Adverse Events for the Overall Treatment Period(Day 1 to Week 12)
- Cumulative Percentage of Abnormal Involuntary Movement Scale (AIMS) Responders by Response Level (Percentage Improvement From Baseline) at Week 12(Day 0 (Baseline), Week 12)