NCT02674321已完成1 期
A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The purpose of this study is to evaluate safety, tolerability and preliminary efficacy of SD-809 in the treatment of motor and phonic tics of Tourette Syndrome and to evaluate the pharmacokinetic of SD-809 and its metabolites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 to 18 years of age, inclusive, at Screening.
- •Patient has a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) diagnosis of Tourette Syndrome and has manifested motor and phonic tics within 3 months before the Screening visit
- •Patient has total tic score of ≥19 on the YGTSS
- •Tic severity and frequency has been stable for at least 2 weeks before the Screening visit
- •Willing to adhere to medication regimen and to comply with all procedures
- •Patient is in good general health, as indicated by medical and psychiatric history and physical examination
- •Patient and parent/guardian have provided written, informed consent (and written assent, as appropriate)
- •Female patients of childbearing potential agree to use an acceptable method of contraception
- •Additional criteria apply, please contact the investigator for more information
排除标准
- •Patient has a serious untreated or undertreated psychiatric illness
- •Patient has a history of suicidal ideation or behavior
- •Patient has received tetrabenazine, neuroleptics, benzodiazepines, topiramate, dopamine receptor antagonists within 14 days of Screening or Baseline; or botulinum toxin within 3 months of Screening or Baseline
- •Patient is being treated with deep brain stimulation for control of tics
- •Patient has a progressive or degenerative neurological disorder or a structural disorder of the brain
- •Patient has participated in an investigational drug or device trial within 30 days of Screening
- •Patient is pregnant or breastfeeding at Screening or Baseline
- •Patient has a history of alcohol or substance abuse in the previous 12 months, as defined in the DSM-V
- •Additional criteria apply, please contact the investigator for more information
研究组 & 干预措施
SD-809
Experimental
• SD-809 tablets taken once or twice daily for 8 weeks, includes a dose titration period and a maintenance period.
干预措施: SD-809 (Drug)
结局指标
主要结局
Safety
时间窗: 8 weeks
Incidence of adverse events (AEs), serious AEs, severe AEs, drug related AEs, AEs leading to withdrawal.
次要结局
- Change from Baseline in Total Tic Score of the Yale Global Tic Severity Scale (YGTSS)(Baseline, Weeks 2, 4 and 8)
- Change from Baseline in Impairment Score of the Yale Global Tic Severity Scale (YGTSS)(Baseline, Weeks 2, 4, and 8)
- Change from Baseline in Global Severity Score of the Yale Global Tic Severity Scale (YGTSS)(Baseline, Weeks 2, 4, and 8)
- Change from Baseline in Tourette Syndrome Clinical Global Impression(Baseline, Weeks 2, 4, and 8)
- Patient Global Impression of Change (TS-PGIC)(Weeks 2, 4, and 8)
研究者
研究点 (1)
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