A Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 506
- 主要终点
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24
研究概览
简要总结
The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).
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
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is an out-patient.
- •The subject presents with a diagnosis of idiopathic Parkinson's disease.
- •Prior therapy with all registered Parkinsonian medication is allowed.
排除标准
- •(For female subjects) The subject is pregnant or lactating.
- •The subject is participating in another clinical study or has done so within the past 30 days.
- •The subject has received neurosurgical intervention related to PD.
- •The subject has relevant renal impairment.
- •The subject has relevant hepatic impairment.
- •The subject is suffering from any dementia or psychiatric illness.
- •The subject has a history of allergic asthma.
研究组 & 干预措施
Sarizotan
干预措施: Sarizotan (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 24
时间窗: Baseline, Week 24
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 24 - Baseline.
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 12
时间窗: Week 12
Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.
Responder Rate Based on Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 at Week 24
时间窗: Week 24
Responder rate was defined as the percentage of subjects with 25% improvement compared to baseline in the sum of UPDRS scores for items 32 and 33. The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Items 32 and 33 assessed duration of dyskinesia and disability due to dyskinesia, respectively. Both items were rated on a 0 to 4-point scale, where higher scores indicated higher duration of dyskinesia and more disability due to dyskinesia, respectively. The Items 32 and 33 composite score was sum of the individual item scores and ranged from 0 to 8, where higher score indicated more complications due to dyskinesia.
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score for Items 18 to 31 at Week 12
时间窗: Baseline, Week 12
The UPDRS was an investigator-assessed rating tool to follow the longitudinal course of Parkinson's disease. Each item from 18 to 31 was rated on a scale ranging from 0 to 4, where higher scores indicated higher complications due to dyskinesia. The total score was the sum of the individual item scores and ranged from 0 to 56, where higher score indicated more complications due to dyskinesia. Change = Week 12 - Baseline.
次要结局
未报告次要终点