Health Condition 1: null- Relapsing Remitting Multiple Sclerosis
Conditions
Interventions
Intervention1: BG00012: 240mg capsule TID
Intervention2: BG00012: 240mg capsule BID
Control Intervention1: Placebo: to match
Sponsors
Biogen Idec
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if BG00012 is effective in reducing the proportion of relapsing subjects at 2 years.Timepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine if BG00012 decreases the number of brain lesions and slows time to progression. To determine the safety and tolerability of BG00012, and the effect it may have on tests and evaluations used to assess MS.Timepoint: 2 years | — |
Countries
India
Contacts
Public ContactMandeep Kaushal
Medical Director
Outcome results
None listed