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NCT02555215 · ClinicalTrials.gov registry record · Phase 3
Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 20
- Enrollment target
NCT02555215: Completed Phase 3 study, sponsored by Biogen.
NCT02555215 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 20 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02555215, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 20 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who completed Study 109MS202 (NCT02410200).
Primary Outcome
An AE is any untoward medical occurrence that does not necessarily have a causal relationship with treatment. An SAE is any untoward medical occurrence that at any dose: results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; any other medic
Interventions
- DRUG dimethyl fumarate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-02-22 |
| Est. Completion | 2018-09-24 |
| Phase | Phase 3 |
What the finished NCT02555215 record still lists
NCT02555215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which dimethyl fumarate is the first listed.
NCT02555215 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02555215 about?
NCT02555215 is a clinical study titled "Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)". The primary objective of the study is to evaluate the long-term safety of BG00012 in subjects who completed Study 109MS202 (NCT02410200). Secondary objectives are as follows: To evaluate the long-term efficacy of BG00012 and to describe the long-term Multiple Sclerosis (MS) outcomes in subjects who ...
What is the current status of trial NCT02555215?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 20 participants. The study started on 2016-02-22. Estimated completion is 2018-09-24.
What interventions are being tested in trial NCT02555215?
The interventions under investigation include: dimethyl fumarate (DRUG).
Who is sponsoring clinical trial NCT02555215?
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 NCT02555215's enrollment target sits among peer trials
20 1956th of 2000 higher than 32 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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