Status:
COMPLETED
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
19-58 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the long-term safety profile of BG00012 (dimethyl fumarate). Secondary objectives of this study are to evaluate the long-term efficacy of BG00012 usi...
Detailed Description
The initial BG00012 dosage for the extension study (240 mg BID or 240 mg TID) was the same as that used in the Phase 3 Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451). Subsequent to the init...
Eligibility Criteria
Inclusion
- Key
- Subjects who participated in and completed as per protocol previous BG00012 clinical studies 109MS301 (NCT00420212) or 109MS302 (NCT00451451).
- Key
Exclusion
- Any significant change in medical history from 109MS301 or 109MS302 that would have excluded subject's participation from their previous study.
- Subjects from 109MS301 or 109MS302 who discontinued oral study treatment due to an AE or due to reasons other than protocol-defined relapse/disability progression.
- Subjects from 109MS301 or 109MS302 who discontinued study treatment due to disability progression or relapses and did not follow the modified visit schedule up to Week 96.
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
February 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2019
Estimated Enrollment :
1736 Patients enrolled
Trial Details
Trial ID
NCT00835770
Start Date
February 3 2009
End Date
November 8 2019
Last Update
December 31 2020
Active Locations (246)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Birmingham, Alabama, United States, 35294
2
Research Site
Huntsville, Alabama, United States, 35801
3
research Site
Mesa, Arizona, United States, 85206
4
Research Site
Phoenix, Arizona, United States, 85013