A SAFETY AND EFFICACY EXTENSION STUDY OF ONO-4641 IN PATIENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS
- Conditions
- Relapsing-remitting Multiple SclerosisMedDRA version: 17.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2010-018705-11-CZ
- Lead Sponsor
- Merck KGaA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 376
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this 225-week active-drug Extension Study is to evaluate the continuing safety and efficacy of ONO-4641 in patients with relapsing-remitting multiple sclerosis (RRMS) in patients who have completed an initial 26-week study (ONO-4641POU006).;Secondary Objective: N/A;Primary end point(s): The number of Gd-enhanced lesions, lesion volume, and brain volume obtained by MRI at Visits 13, 16, 20, 24, 27, 29, Follow-up Visit 30 and Early Termination Visit will be compared with that of the baseline of the Extension Study<br><br>;Timepoint(s) of evaluation of this end point: Visits 13, 16, 20, 24, 27, 29, Follow-up Visit 30 and Early Termination Visit
- Secondary Outcome Measures
Name Time Method Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A