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

EWRON PHARMACEUTICALS SpA.,0 个研究点目标入组 23 人开始时间: 2010年10月25日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•The subject has completed a previous clinical study with safinamide in PD, and;
•The subject successfully completed all the requirements of the previous study, and;
•For patients for whom this open study is not yet available due to a longer implementation of the study in the centers, the maximum period of time without safinamide treatment is 12 months. Note: If the last visit of the previous study cannot be used as the baseline evaluation of the open study, a complete baseline examination should be performed.
•If you are a woman, you must be postmenopausal for at least 2 years, have been surgically sterilized or have undergone a hysterectomy or, if you are of childbearing age, you must be willing to avoid pregnancy by using an appropriate contraceptive method for four weeks before the study, during the same and four weeks after the last dose of the study medication. For the purpose of this study, women of childbearing age are defined as all women after puberty unless they are postmenopausal for at least 2 years, have been surgically sterilized or sexually inactive, and;
•Subjects must be willing and able to participate in this study and give written informed consent.

•The subject presented a clinically significant adverse effect attributable to the medicinal product under investigation during a previous study that could put the subject at risk if he continues with safinamide treatment.
•If you are a woman, you are pregnant or breastfeeding
•Any medical problem that has arisen from the initial clinical study that, at the discretion of the researcher, prevents the subject from participating in this open study.

发起方

EWRON PHARMACEUTICALS SpA.,