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COMPLETEDPhase 3NCT00451451

Efficacy and Safety Study of Oral BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis

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 ...

Lead sponsor: Biogen•72 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Biogen

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 young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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 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.

Exclusion Criteria

•Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
•Pregnant or nursing women

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 26, 2015Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment1,417

Start dateJun 2007

Last updatedJan 26, 2015

Condition

Relapsing-Remitting Multiple Sclerosis

Locations shown

Research Site

Birmingham, Alabama

Research Site

Cullman, Alabama

Research Site

Huntsville, Alabama

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2015Data synced to Clareo: May 17, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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