NCT00203164已完成3 期
A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 6
- 主要终点
- long-term safety and tolerability of rasagiline or levodopa/benserazide (LD/BZD) therapy
研究概览
简要总结
This is a study to look at the effectiveness, tolerability, and safety of one dose of rasagiline in advanced Parkinson's disease (PD) patients who have been treated with Levodopa/Carbidopa therapy.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have completed the Week 26 visit of TVP 1012/133 (Visit 06) in accordance with the protocol.
- •Women must be postmenopausal, surgically sterile, or using adequate birth control methods. Women of childbearing potential must have a negative pregnancy test at Baseline/Month
- •Patients must be willing and able to give informed consent.
排除标准
- •Serious or severe, test drug-related (probable or definite) adverse reaction in study TVP 1012/
- •Premature discontinuation from study TVP 1012/133 for any reason.
- •A clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases; or malignancies, as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or electrocardiogram (ECG).
研究组 & 干预措施
rasagiline mesylate
Experimental
rasagiline mesylate 1 mg oral once daily
干预措施: rasagiline mesylate (Drug)
结局指标
主要结局
long-term safety and tolerability of rasagiline or levodopa/benserazide (LD/BZD) therapy
时间窗: until commericially available
To evaluate the long-term safety and tolerability of rasagiline in PD patients with motor fluctuations treated with chronic levodopa/carbidopa (LD/CD) or levodopa/benserazide (LD/BZD) therapy
次要结局
未报告次要终点
研究者
研究点 (6)
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