Status:
COMPLETED
An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
This is a multicenter study conducted in 2 parts: The primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonan...
Eligibility Criteria
Inclusion
- Key
- Inclusion Criteria for Part I:
- Must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS).
- Must have a baseline Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0, inclusive.
- Key Inclusion Criteria for Part II:
- • Subjects who participated in and completed Part I per protocol.
- Key
Exclusion
- 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 :
March 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 4 2018
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01838668
Start Date
March 28 2013
End Date
September 4 2018
Last Update
November 20 2018
Active Locations (54)
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1
Fakultni nemocnice u sv. Anny v Brne
Brno, Czechia, 656 91
2
Neurospol, s.r.o.
Havířov, Czechia, 736 00
3
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
4
Privatni ordinace - neurologie
Hradec Králové, Czechia, 50003