Status:
COMPLETED
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of br...
Eligibility Criteria
Inclusion
- Key
- Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
- Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
- Must have a baseline EDSS between 0.0 and 5.0, inclusive.
- Must have relapsing-remitting disease course.
- Key
Exclusion
- Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
- Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
- Pregnant or nursing women.
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
1234 Patients enrolled
Trial Details
Trial ID
NCT00420212
Start Date
January 1 2007
End Date
February 1 2011
Last Update
January 26 2015
Active Locations (159)
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1
Research Site
Gilbert, Arizona, United States
2
Research Site
Phoenix, Arizona, United States
3
Research Site
San Francisco, California, United States
4
Research Site
New Haven, Connecticut, United States