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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 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 1,736 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00835770
The ClinicalTrials.gov registry entry for NCT00835770 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,736 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00835770 reports 0 study locations.
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.
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