Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
156actual
Sites
62
Countries
Belgium, Bulgaria, Canada +15
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2014-08-28 | actual | When the study began enrolling |
| Primary completion | 2025-07-08 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-08 | actual | The whole study's end, after follow-up |
| First posted | 2014-11-05 | estimated | When this record first appeared on the registry |
| Results posted | 2026-05-19 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-05-19 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Relapsing-Remitting Multiple Sclerosis
Interventions
- Drug: dimethyl fumarate — also filed as BG00012, Tecfidera
- Drug: Interferon β-1a — also filed as Avonex
Primary outcomes
what the primary-completion date above is the date OFPart 1: Proportion of Participants Free of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans
measured At Week 96
Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
measured From Week 96 up to last follow-up visit (up to Week 340)
Part 2: Number of Participants Who Discontinued Study Treatment Due to an AE
measured From Week 96 up to last follow-up visit (up to Week 340)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2017-07-25 · 4.9 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-07-14 · 1.7 MB · SAP_001.pdf
Publications
- PMID 36169959 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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