OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND

MERCK SERONO SA0 个研究点目标入组 700 人开始时间: 2009年4月15日最近更新: 2021年12月21日

适应症

试验速览

暂无简介。

•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. 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 postmenopausal for at least two years, are surgically sterile or are sexually inactive, and; 4. 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

•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.

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