NCT00203177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
- 8
- 主要终点
- long-term safety and tolerability of rasagiline
研究概览
简要总结
Study to look at the effectiveness, tolerability and safety of two doses of Rasagiline (0.5 mg and 1mg) 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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, metabolic diseases or malignancies as determined by medical history, physical exam, skin evaluation, laboratory tests, chest x-ray, or ECG.
研究组 & 干预措施
Experimental 1
Experimental
0.5 mg rasagiline mesylate oral once daily
干预措施: rasagiline mesylate (Drug)
Expermental 2
Experimental
1.0 mg rasagiline mesylate oral once daily
干预措施: rasagiline mesylate 1.0 mg (Drug)
结局指标
主要结局
long-term safety and tolerability of rasagiline
时间窗: 6 months
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
- long- term clinical effect of rasagiline(6 months)
研究者
研究点 (8)
Loading locations...
相似试验
已完成
3 期
Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease PatientsParkinson's DiseaseNCT00203164Teva Branded Pharmaceutical Products R&D, Inc.254
已完成
1 期
A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of RasagilineParkinson's DiseaseNCT01879748Teva Branded Pharmaceutical Products R&D, Inc.64
终止
3 期
Efficacy, Tolerability and Safety of Azilect in Subjects With Progressive Supranuclear PalsyProgressive Supranuclear PalsyNCT01187888Prof. Dr. Stefan Lorenzl44
已完成
3 期
A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)Depressive Disorder, MajorNCT02943564Naurex, Inc, an affiliate of Allergan plc658
已完成
3 期
A Safety, Efficacy and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric and Adult Subjects With Primary Generalized Tonic-Clonic (i.e., Grand Mal) Seizures.Generalized Tonic Clonic SeizuresNCT01747915Pfizer's Upjohn has merged with Mylan to form Viatris Inc.219