NCT01300819已完成4 期
Multicenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 349
- 试验地点
- 87
- 主要终点
- Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score
研究概览
简要总结
The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female, ≥18 years of age
- •Subject has idiopathic Parkinson's disease with at least 2 of the following cardinal signs being present: bradykinesia, resting tremor, rigidity or postural instability, and without any other known or suspected cause of Parkinsonism
- •Subject has a Hoehn and Yahr stage score ≤4
- •Subject has a total Non-Motor Symptoms Scale (NMSS) score ≥40
- •If the subject is taking levodopa (L-DOPA), he/she must be on a stable dose of L-DOPA (in combination with benserazide or carbidopa) for at least 28 days prior to the Baseline Visit
- •If the subject is receiving anticholinergics, monoamine oxidase (MAO) B inhibitors, or amantadine, he/she must have been on a stable dose for at least 28 days prior to the Baseline Visit and must be maintained on that dose for the duration of the study
排除标准
- •Subject discontinued from previous therapy with a dopamine agonist after an adequate length of treatment, at an adequate dose, due to lack of efficacy as assessed by the investigator
- •Subject is receiving therapy with 1 of the following drugs, either concurrently or within 28 days prior to the Baseline Visit: alpha-methyl dopa, metoclopramide, reserpine, neuroleptics (except specific atypical neuroleptics: olanzapine, ziprasidone, aripiprazole, clozapine, and quetiapine), monoamine oxidase-A (MAO-A) inhibitors, methylphenidate, amphetamine, or other dopamine agonists (DAs)
- •Subject is receiving central nervous system (CNS) therapy (eg, sedatives, hypnotics, selective serotonin reuptake inhibitors [SSRIs], anxiolytics, or other sleep-modifying medication) unless dose has been stable daily for at least 28 days prior to the Baseline Visit and is likely to remain stable for the duration of the study
- •Subject has evidence of an impulse control disorder according to the modified Minnesota Impulsive Disorders Interview at the Screening Visit (Visit 1), confirmed by a positive structured clinical interview
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
Rotigotine
Experimental
干预措施: Rotigotine (Drug)
结局指标
主要结局
Change From Baseline to the End of Maintenance in Total Nonmotor Symptoms Scale (NMSS) Score
时间窗: From Baseline (Day 1) to end of 12-week Maintenance (Day 84)
The Nonmotor Symptoms Scale (NMSS) is a validated tool for rating frequency and severity of nonmotor symptoms in Parkinson's Disease (PD). The severity and frequency of the subject's nonmotor symptoms is assessed by the investigator in the following 9 domain categories: cardiovascular, including falls; sleep/fatigue; mood/cognition; perceptual problems/hallucinations; attention/memory; gastrointestinal tract; urinary; sexual function; miscellaneous. Severity and frequency are rated using a 4-point scale ranging from 0 (none) to 3 (severe; major source of distress or disturbance to subject) for severity and from 1 (rarely) to 4 (very frequent \[daily or all the time\]) for frequency. The total NMSS score ranges from 0 to 350. A negative change from Baseline to end of Maintenance indicates an improvement in NMSS.
次要结局
- Change From Baseline to the End of Maintenance in Total Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score(From Baseline (Day 1) to end of 12-week Maintenance (Day 84))
- Change From Baseline to the End of Maintenance in Health-related Quality of Life (HRQL) Measured by a 39-item Parkinson's Disease Questionnaire (PDQ-39)(From Baseline (Day 1) to end of 12-week Maintenance (Day 84))
- Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Cardiovascular(From Baseline (Day 1) to end of 12-week Maintenance (Day 84))
- Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sleep/Fatigue(From Baseline (Day 1) to end of 12-week Maintenance (Day 84))
- Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Mood/Cognition(From Baseline (Day 1) to end of 12-week Maintenance (Day 84))
- Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Perception/Hallucinations(From Baseline (Day 1) to end of 12-week Maintenance (Day 84))
- Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Attention/Memory,(From Baseline (Day 1) to end of 12-week Maintenance (Day 84))
- Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Gastrointestinal Tract(From Baseline (Day 1) to end of 12-week Maintenance (Day 84))
- Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Urinary(From Baseline (Day 1) to end of 12-week Maintenance (Day 84))
- Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Sexual Function(From Baseline (Day 1) to end of 12-week Maintenance (Day 84))
- Change From Baseline to the End of Maintenance in the Nonmotor Symptoms Scale Score: Subdomain Miscellaneous(From Baseline (Day 1) to end of 12-week Maintenance (Day 84))
研究者
研究点 (87)
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