A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS

Merck KGaA0 个研究点目标入组 376 人开始时间: 2010年8月5日最近更新: 2015年2月16日

适应症

试验速览

暂无简介。

•Patients will be eligible to participate in this study if they meet all of the following criteria:
•1. Completed 26 weeks of double-blind phase of Study ONO-4641POU006
•2. For females:
•a. Patients of childbearing potential who agree to use an acceptable form of birth control (i.e. double barrier method; diaphragm plus condom, intrauterine device plus condom, hormonal contraception plus condom, spermicidal gel plus condom, or abstinence) throughout the study and until 2 months after the last dose;
•b. Negative serum and urine human chorionic gonadotropin (hCG) assay at Visit 9;
•3. For males:
•a. Agree to use a condom with spermicide when engaging in sexual intercourse during participation in the study and until 2 months after the last dose;
•b. Agree to refrain from sperm donation during participation in the study and until 2 months after the last dose;
•4. Able and willing to provide signed, written, Informed Consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 376
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•Patients will not be eligible to participate in this study if any of the following criteria apply:
•1. Presence of any dermatological abnormalities during Study ONO-4641POU006 that in the opinion of the investigator or the Sponsor (Ono Pharmaceutical Co., Ltd.) could increase the risk of the patient developing a skin cancer;
•2. In the opinion of the Investigator, a patient who may not be able to cooperate fully with the study staff, may have difficulty in some study requirements, or is otherwise not qualified for the study.

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