EUCTR2008-005492-94-GB进行中（未招募）1 期
Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients
Merck Serono S.A. - Geneva0 个研究点目标入组 1,285 人开始时间: 2009年9月1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
- 入组人数
- 1,285
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
入选标准
- •To be eligible for inclusion into this trial, subjects must fulfill all of the following criteria:
- •1.The subject has completed a previous clinical study with safinamide in PD, and;
- •2.The subject successfully completed all trial requirements of the antecedent trial, and;
- •3. For those patients for which this open label study is not yet available due to longer implementation of the study in the sites, the maximum time period off safinamide treatment is 12 months; NB: if the last visit of the antecedent study cannot be used as the baseline evaluation of the OL-study, a complete baseline examination must be performed.
- •4.If female, they must be either post menopausal for at least 2 years, surgically sterilized or have undergone hysterectomy or, if of child bearing potential they must be willing to avoid pregnancy by using an adequate method of contraception for four weeks prior to, during and four weeks after the last dose of study medication. For the purpose of this trial, women of childbearing potential are defined as all female subjects after puberty unless they are post-menopausal for at least two years, are surgically sterile or are sexually inactive, and;
- •5.Subjects must be willing and able to participate in the trial and provide written informed consent.
- •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
- •To be eligible for inclusion in this trial the subjects must not satisfy any of the following criteria:
- •1.The subject experienced a clinically significant adverse effect to attributable to Investigational Medicinal Product (IMP) during a previous trial that could put the subject at risk for further treatment with safinamide.
- •2.If female, the subject is pregnant or lactating.
- •3.Any medical issues, which have emerged since the initial clinical trial, that in the opinion of the investigator precludes a subject’s ability to participate in this open-label trial.
研究者
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