A clinical trial to determine the efficacy and safety of BG00012 in patients with relapsing remitting multiple sclerosis.
- Conditions
- Health Condition 1: null- Relapsing Remitting Multiple Sclerosis
- Registration Number
- CTRI/2009/091/000088
- Lead Sponsor
- Biogen Idec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1011
a). Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
b). Aged 18 to 55 years old, inclusive, at the time of informed consent.
c). Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
d). Must have a baseline EDSS between 0.0 and 5.0, inclusive.
e). Must have relapsing-remitting disease course.
a). Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
b). Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
c). 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