A Double-Blind, Placebo-Controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan 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
- 398
- 主要终点
- Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12
研究概览
简要总结
The purpose of this study is to test multiple doses of sarizotan to establish a dose with maximal safety and efficacy for treating treatment associated dyskinesia in Parkinson's disease participants.
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
- Double (Participant, Investigator)
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 participant is an out-patient
- •The participant presents with a diagnosis of idiopathic Parkinson's disease
- •Prior therapy with all registered Parkinsonian medication is allowed
排除标准
- •(For female participants) The participant is pregnant or lactating
- •The participant is participating in another clinical study or has done so within the past 30 days
- •The participant has received neurosurgical intervention related to Parkinson's disease
- •The participant has relevant renal impairment
- •The participant has relevant hepatic impairment
- •The participant is suffering from any dementia or psychiatric illness
- •The participant has a history of allergic asthma
研究组 & 干预措施
Sarizotan 4 mg/day
Participants will receive sarizotan 4 mg/day (given in 2 divided daily doses) up to Week 12.
干预措施: Sarizotan (Drug)
Sarizotan 10 mg/day
Participants will receive sarizotan 10 mg/day (given in 2 divided daily doses) up to Week 12.
干预措施: Sarizotan (Drug)
Placebo
Participants will receive placebo matched to sarizotan tablet orally twice daily up to Week 12.
干预措施: Placebo (Drug)
Sarizotan 2 milligrams per day (mg/day)
Participants will receive sarizotan 2 milligrams (mg) per day (given in 2 divided daily doses) up to Week 12.
干预措施: Sarizotan (Drug)
结局指标
主要结局
Change From Baseline in Diary-Based On-Time Without Dyskinesia at Week 12
时间窗: Baseline, Week 12
On-time without dyskinesia was defined as a period (in hours) when the participant had no symptoms of off-time and was not asleep; also, participant had no difficulty in performing voluntary movements (that is, without dyskinesia). Off-time was defined as a period (in hours) when participant experienced increased parkinsonian symptoms (e.g. immobility or inability to move with ease). On-time was recorded by participant in a participant diary.
次要结局
- Change From Baseline in Modified Abnormal Involuntary Movement Scale (AIMS) Score at Week 12(Baseline, Week 12)
- Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Items 32 and 33 Composite Score at Week 12(Baseline, Week 12)
- Change From Baseline in UPDRS Part III Total Score at Week 12(Baseline, Week 12)