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ENDORSE: Long-Term Safety and Efficacy of BG00012 in RRMS
NCT00835770Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2009
- Primary completion
- Nov 2019
- Countries
- 34
- Sponsor
- Biogen
- Modality
- Small Molecules
- Drugs
- dimethyl fumarate
- Conditions
- relapsing-remitting multiple sclerosis (RRMS)
01
Overview
Phase 3, double-blind trial of dimethyl fumarate in relapsing-remitting multiple sclerosis (RRMS) (2 arms), sponsored by Biogen. Primary endpoint: Number of Participants With Treatment-Emergent Adverse Events (AEs). Started Feb 2009; status: completed.
02
Design
2 arms- Study design
- Non-randomizedDouble-blind
BG00012 240 mg BID
Dimethyl fumarate 240 mg twice daily (plus placebo once daily during blinded phase).
BG00012 240 mg TID
Dimethyl fumarate 240 mg three times daily (during blinded phase), then switching to BID.
03
Who it enrols
Participants must have completed the previous BG00012 clinical studies 109MS301 (DEFINE) or 109MS302 (CONFIRM) according to protocol.
04
Endpoints
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Secondary
Percentage of Participants Who Had Relapses
Annualized Relapse Rate (ARR)
Change From Baseline in the Expanded Disability Status Scale (EDSS)
Number of Gadolinium (Gd)-Enhancing Lesions
Volume of Gadolinium (Gd)-Enhancing Lesions
Number of New or Newly Enlarging T2 Lesions
Volume of New or Newly Enlarging T2 Lesions
Number of T1 Hypointense Lesions
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