A phase II, multicentre study to evaluate the long-term safety and efficacyof MT-1303 in subjects with relapsing-remitting multiple sclerosis whohave completed the MT-1303-E04 study
Phase 1
- Conditions
- Relapsing-remitting multiple sclerosis (RRMS)Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2012-002639-27-IT
- Lead Sponsor
- MITSUBISHI TANABE PHARMA CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 367
Inclusion Criteria
Completion of the 24-week Treatment Period in MT-1303-E04 as per
protocol
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 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
1. Permanent discontinuation of study medication prior to the End of
Treatment (EOT) Visit in MT-1303-E04
2. Newly diagnosed diabetes mellitus during MT-1303-E04
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method