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NCT00835770 · ClinicalTrials.gov registry record · Phase 3
BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,736
- Enrollment target
NCT00835770: Completed Phase 3 study, sponsored by Biogen.
NCT00835770 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 1,736 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (125% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00835770, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,736 participants
- Enrollment target
Study 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 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG00012 on multiple sclerosis (MS) brain lesions on magnetic resonance imaging (MRI) scans in participants who had MRI scans as part of Studies 109MS301 (NCT00420212) and 109MS302 (NCT00451451) and to evaluate the long-term effects of BG00012 on health economics assessments and the visual function test.
Primary Outcome
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Interventions
- DRUG Placebo
- DRUG dimethyl fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,736 participants |
| Start Date | 2009-02-03 |
| Est. Completion | 2019-11-08 |
| Phase | Phase 3 |
What the finished NCT00835770 record still lists
NCT00835770 is an interventional study that assigns participants to a tested intervention. Its 1,736 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (125% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00835770 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00835770 about?
NCT00835770 is a clinical study titled "BG00012 Monotherapy Safety and Efficacy Extension Study in Multiple Sclerosis (MS)". 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 using clinical endpoints and disability progression, to evaluate further the long-term effects of BG000...
What is the current status of trial NCT00835770?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,736 participants. The study started on 2009-02-03. Estimated completion is 2019-11-08.
What interventions are being tested in trial NCT00835770?
The interventions under investigation include: Placebo (DRUG), dimethyl fumarate (DRUG).
Who is sponsoring clinical trial NCT00835770?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00835770's enrollment target sits among peer trials
1,736 129th of 2000 higher than 1,871 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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