A Randomized, Double-blind, Placebo-controlled Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 42
- 主要终点
- Change From Baseline in the TTS of the YGTSS at Week 12
研究概览
简要总结
This is a study to evaluate the efficacy and safety of deutetrabenazine (TEV-50717) tablets for the reduction of motor and phonic tics associated with TS in children and adolescents 6 through 16 years of age.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is 6 to 16 years of age, inclusive.
- •Participant weighs at least 44 pounds (20 kilograms [kg]).
- •The participant's active tics are causing distress or impairment.
- •Participant is able to swallow study medication whole.
- •Participant is in good general health.
- •Women/girls of childbearing potential whose male partners are of childbearing potential must use contraception for the duration of the study.
- •Additional criteria apply, please contact the investigator for more information
排除标准
- •Participant has a neurologic disorder other than TS that could obscure the evaluation of tics.
- •Participant has a confirmed diagnosis of bipolar disorder, schizophrenia, or another psychotic disorder.
- •Participant has clinically significant depression at screening or baseline.
- •Participant has a history of suicidal intent or related behaviors within 2 years of screening.
- •Participant has a history of a previous actual, interrupted, or aborted suicide attempt.
- •Participant has a first-degree relative who has completed suicide.
- •Participant has received comprehensive behavioral intervention for tics (CBIT) for TS or cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) within 4 weeks of screening.
- •Participant has an unstable or serious medical illness at screening or baseline.
- •Participant is pregnant or breastfeeding.
- •Additional criteria apply, please contact the investigator for more information.
研究组 & 干预措施
TEV-50717
TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 12 weeks
干预措施: TEV-50717 (Drug)
Placebo
Placebo matched to TEV-50717 BID for a total of 12 weeks
干预措施: Placebo (Drug)
TEV-50717
TEV-50717 tablets twice daily (BID) up to 48 milligrams (mg)/day orally for a total of 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the TTS of the YGTSS at Week 12
时间窗: Baseline, Week 12
YGTSS rating scale is a semi-structured clinician rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic tics. YGTSS is composed of 11 items: 5 items for motor tic severity, 5 items for vocal tic severity, and 1 item for impairment. Each item for motor tic severity and vocal is rated on a 6-point scale (0 for none to 5 to severe). MTSS is the sum of the 5 items for motor tic severity and VTSS is the sum of the 5 items for vocal tic severity. TTS is the sum of MTSS and VTSS, ranges from 0 (none/absent) to 50 (severe). Higher scores indicate greater severity/worse outcome. Least square (LS) mean and standard error (SE) was calculated using mixed-model repeated-measures (MMRM) with treatment group, week (5 levels: weeks 2, 4, 6, 9, and 12), and the treatment group by week interaction as fixed effects; and baseline TTS, region, and age group at baseline (2 levels: 6 to 11 years, 12 to 16 years) as covariates.
次要结局
- Change From Baseline in the Tourette Syndrome-Clinical Global Impression (TS-CGI) Score at Week 12(Baseline, Week 12)
- Change From Baseline in the Tourette Syndrome-Patient Global Impression of Impact (TS-PGII) Score at Week 12(Baseline, Week 12)
- Change From Baseline in the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life (C&A-GTS-QOL) Activities of Daily Living (ADL) Subscale Score at Week 12(Baseline, Week 12)
- Percentage of Participants With Adverse Events(Baseline (Day 1) to follow-up (Week 14))