A Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's Disease

Teva Branded Pharmaceutical Products R&D, Inc.0 个研究点目标入组 306 人开始时间: 2004年6月最近更新: 2011年4月12日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Teva Branded Pharmaceutical Products R&D, Inc.
入组人数: 306
主要终点: Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout)

研究概览研究设计入排标准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

Patients who completed the study TVP-1012/232 are eligible to enter the extension study to continue their rasagiline therapy for their Parkinson's disease (PD). During this study the patient's safety, tolerability of rasagiline, and effectiveness of this therapy will be monitored.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 35 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients who completed evaluations of week 52 of the TVP 1012/232 protocol, where continued rasagiline therapy is warranted, in the opinion of the principal investigator

排除标准

•Patients having suffered adverse effects that were probably drug-related in the TVP-1012/232 study

结局指标

主要结局

Tolerability - Number of patients completing study on their original treatment assignment (dose reduction and dropout)

时间窗: 2.5 years

次要结局

未报告次要终点

研究者

发起方

Teva Branded Pharmaceutical Products R&D, Inc.

申办方类型

Industry

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