Open Label Extension Study With Pramipexole (PPX) in Children With Tourette Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 45
- 试验地点
- 14
- 主要终点
- Patients With Adverse Events Leading to Discontinuation of Trial Drug
研究概览
简要总结
The primary objective of this open-label, flexible dose study is to assess the safety and efficacy of pramipexole over a 24-week period in children and adolescents (age 6-17 years inclusive) diagnosed with Tourette Syndrome according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and who have completed either Study 248.641 (NCT 00681863) or 248.644 (NCT 00558467).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
pramipexole 0.0625 mg BID (twice daily)
all patients to receive one tablet of pramipexole 0.0625 mg BID for first 4 weeks (flexible dosing for all other arms)
干预措施: pramipexole 0.0625 mg BID (Drug)
pramipexole 0.0625 mg QD (once daily)
patients to receive one tablet of pramipexole 0.0625 mg QD
干预措施: pramipexole 0.0625 mg QD (Drug)
pramipexole 0.125 mg BID
patients to receive one tablet of pramipexole 0.125 mg BID
干预措施: pramipexole 0.125 mg BID (Drug)
pramipexole 0.125 mg TID (three times daily)
patients to receive one tablet of pramipexole 0.125 mg TID
干预措施: pramipexole 0.125 mg TID (Drug)
pramipexole 0.25 mg BID
patients to receive one tablet of pramipexole 0.25 mg BID
干预措施: pramipexole 0.25 mg BID (Drug)
结局指标
主要结局
Patients With Adverse Events Leading to Discontinuation of Trial Drug
时间窗: 24 Weeks
Number of patients with Adverse Events leading to discontinuation of trial drug
次要结局
- Mean Change From Baseline in Total Tic Score (TTS) of the Yale Global Tic Severity Scale(baseline and Week 20)
- Mean Change From Baseline in Total Score of the Yale Global Tic Severity Scale(baseline and Week 24)
- Clinical Global Impressions - Severity of Illness(week 24)
- Clinical Global Impressions - Severity of Illness, Categorized(week 24)
- Clinical Global Impressions - Improvement(week 24)
- Patient Global Impression - Improvement(week 24)
- Frequency of Patients With Possible Clinically Significant Abnormalities for Laboratory Parameters(Baseline and 24 weeks)