临床试验/NCT01032486

NCT01032486已完成不适用

An Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease Subjects

Teva Branded Pharmaceutical Products R&D, Inc.0 个研究点目标入组 120 人开始时间: 2009年12月最近更新: 2013年8月28日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Teva Branded Pharmaceutical Products R&D, Inc.
入组人数: 120
主要终点: Change from baseline to end of the study in sleep disturbances as measured with the Parkinson's Disease Sleep Scale (PDSS).

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The main objective of this study is to evaluate the effect of Azilect® on sleep disturbances in Parkinson's Disease patients, after 2 months of treatment.

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•idiopathic Parkinson's disease.
•eligible to Azilect® treatment as per Canadian product monograph

排除标准

•exclusion (e.g. drug-drug interactions, contraindications, warnings and precautions) based on the Canadian product monograph.
•investigational drug within 30 days prior to study
•use of Azilect® or selegiline within 60 days prior to study
•significant medical condition

研究组 & 干预措施

Azilect

Subjects with a diagnosis of idiopathic Parkinson's disease eligible to Azilect® treatment based on the investigator's clinical assessment and according to the Canadian product monograph.

干预措施: Rasagiline mesylate (Drug)

结局指标

主要结局

Change from baseline to end of the study in sleep disturbances as measured with the Parkinson's Disease Sleep Scale (PDSS).

时间窗: 2 months

次要结局

Change from baseline to end of the study in daytime sleepiness as measured with the Epworth Sleepiness Scale (ESS).(2 months)

研究者

发起方

Teva Branded Pharmaceutical Products R&D, Inc.

申办方类型

Industry

责任方

Sponsor

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