NCT01744496已完成4 期
A Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 16
- 主要终点
- Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale
研究概览
简要总结
This trial is being conducted to compare the impact of Rotigotine and Placebo on Chronic Pain associated with Parkinson's Disease among patients with advanced stages of the 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
- Triple (Participant, 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
- •Patient has advanced idiopathic Parkinson's Disease associated chronic pain assessed by a Likert Pain Scale
- •Patient is taking Levodopa with a stable daily dose of at least 200 mg for at least 21 days prior to start
- •Hoehn and Yahr stage score of II to IV
- •Mini-Mental State Examination (MMSE) score ≥ 25
- •If an antidepressant drug is taken, the dose must be stable for at least 21 days
排除标准
- •Therapy with a Dopamine Agonist within 21 days prior to start
- •Discontinuation from previous Dopamine Agonist Therapy due to lack of efficacy
- •Therapy with Dopamine-modulating substances 21 days prior to start
- •Therapy with analgesics for the treatment for pain, unless the dose has been stable
- •Chronic alcohol or drug abuse
- •Medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study
- •Hypersensitivity to any components of the Investigational Medicinal Product (IMP) or comparative drugs
- •Atypical Parkinson's Disease Syndrome due to drugs
- •History of deep brain stimulation
- •Significant skin disease that would make transdermal drug use inappropriate
- •Electroconvulsive therapy within 12 weeks prior to start
- •Evidence of an Impulse Control Disorder
- •Previous diagnosis of severe Restless Legs Syndrome
- •Chronic Migraine
- •Severe Depression
- •Symptomatic Orthostatic Hypotension
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo Transdermal Patches
干预措施: Placebo (Drug)
Rotigotine
Experimental
Rotigotine Transdermal Patches
干预措施: Rotigotine (Drug)
结局指标
主要结局
Change From Baseline to the End of the Maintenance Period in Pain Severity Assessed Using an 11-point Likert Pain Scale
时间窗: Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after an up to 7 weeks Titration Period)
An 11-Point Likert Scale was used to assess patients' average daily pain. The subject rated his/her average pain from 0 (no pain) to 10 (worst pain ever experienced). The average pain experienced in the last 7 days was calculated by the mean of the daily Likert Pain Scores within the 7 days prior to the respective visit (ie, Likert Pain Scores with a date of assessment before the date of visit and on or after the date of visit - 7 days). A negative value indicates an improvement.
次要结局
- Percentage of Responders at the End of the Maintenance Period(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
- Change From Baseline to the End of the Maintenance Period in the 7-Item Depression Subscore of the Hospital Anxiety and Depression Scale (HADS)(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
- Change From Baseline to the End of the Maintenance Period in the Sum Score of the 8-Item Parkinson's Disease Questionnaire (PDQ-8)(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
- Change From Baseline to the End of the Maintenance Period in the 7-Item Anxiety Subscore of the Hospital Anxiety and Depression Scale (HADS)(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
- Change From Baseline to the End of the Maintenance Period in the 7 Domain Scores of Classification of Pain in Parkinson's Disease(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
- Change From Baseline to the End of the Maintenance Period in the Combined Score of the Unified Parkinson's Disease Rating Scale (UPDRS) Parts II (Activities of Daily Living [ADL] Subscale) and III (Motor Subscale)(Baseline (Visit 2) until End of the Maintenance Period (Maintenance Period lasts 12 weeks ± 5 days after up to 7 weeks Titration Period))
研究者
研究点 (16)
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