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

• Conditions: Relapsing-remitting Multiple Sclerosis; MedDRA version: 14.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-018705-11-BE
• Lead Sponsor: Merck Serono S.A. - Geneva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-13
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified