A clinical trial to determine the efficacy and safety of BG00012 in patients with relapsing remitting multiple sclerosis.
Phase 3
Completed
- Registration Number
- CTRI/2009/091/000117
- Lead Sponsor
- Biogen Idec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1232
Inclusion Criteria
a). Aged 18 to 55 years old, inclusive at the time of informed consent.
b). Must have confirmed diagnosis of RRMS according to McDonald criteria #1-4.
c). Must have a baseline EDSS between 0.0 and 5.0, inclusive.
d). Must have relapsing-remitting disease course.
Exclusion Criteria
a). Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
b). Pregnant or nursing women
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method