EUCTR2004-000835-27-ES进行中（未招募）1 期
A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.
ewron Pharmaceuticals S.P.A0 个研究点目标入组 0 人开始时间: 2006年5月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet all of the following inclusion criteria to be eligible for enrolment into the study:
- •1. The patient completed 24 weeks of treatment in Study 015, or if the patient discontinued prematurely, he/she returned for scheduled efficacy evaluations at Weeks 12 and 24 (Visits 6 and 8) as part of the Retrieved Dropout (RDO) population.
- •2. The patient was compliant with taking study medication in Study 015.
- •3. The patient is willing to participate in the study and signed an approved Informed Consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The presence of any of the following will exclude a patient from study enrollment:
- •1. The patient is experiencing clinically significant adverse events that would put the patient at risk for participating in the study.
- •2. The patient has shown clinically significant deterioration during participation in Study 015.
- •3. The patient discontinued Study 015 prematurely for any reason, and did not return for all scheduled efficacy evaluations Weeks 12 and 24 (Visits 6 and 8) in Study 015.
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