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NCT01156311 · ClinicalTrials.gov registry record · Phase 2
BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis
A Phase 2 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 2
- Development phase
- 108
- Enrollment target
NCT01156311: Completed Phase 2 study, sponsored by Biogen.
NCT01156311 is a Phase 2 study that has completed, run by Biogen. The registered enrollment target is 108 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01156311, a Phase 2 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 108 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).
Primary Outcome
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life-threatening event); required inpatient hospitalization or prolongation of existing hospitalization;
Interventions
- DRUG dimethyl fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT01156311 record still lists
NCT01156311 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 1 intervention - of which dimethyl fumarate is the first listed.
NCT01156311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01156311 about?
NCT01156311 is a clinical study titled "BG00012 Phase 2 Combination Study in Participants With Multiple Sclerosis". The primary objective of the study is to evaluate the safety and tolerability of BG00012 (dimethyl fumarate) administered in combination with interferon b (IFNß) or glatiramer acetate (GA) in participants with relapsing-remitting multiple sclerosis (RRMS).
What is the current status of trial NCT01156311?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2010-06. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01156311?
The interventions under investigation include: dimethyl fumarate (DRUG).
Who is sponsoring clinical trial NCT01156311?
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 NCT01156311's enrollment target sits among peer trials
108 640th of 2000 higher than 1,355 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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