Status:
COMPLETED
Efficacy and Safety Study of Oral BG00012 With Active Reference 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. Other goals of the study are to determine if, over time, BG00012 treatment can decrease the ...
Detailed Description
Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. It is predominantly a disease of y...
Eligibility Criteria
Inclusion
- Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
- Key
- Must have 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
- Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
- Pregnant or nursing women
- Note: Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
1417 Patients enrolled
Trial Details
Trial ID
NCT00451451
Start Date
June 1 2007
End Date
August 1 2011
Last Update
January 26 2015
Active Locations (195)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Cullman, Alabama, United States
3
Research Site
Huntsville, Alabama, United States
4
Research Site
Phoenix, Arizona, United States