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NCT02283853 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
NCT02283853 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 156 participants.
The verdict
NCT02283853, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 156 participants
- Enrollment target
Study Summary
The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric participants with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and evolution of disability. The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in participants who completed Week 96 in Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term MS outcomes of BG00012 in participants who completed Week 96 in Part 1 of Study 109MS306.
Interventions
- DRUG dimethyl fumarate
- DRUG Interferon β-1a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2014-08-28 |
| Est. Completion | 2025-07-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02283853
The ClinicalTrials.gov registry entry for NCT02283853 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 156 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 dimethyl fumarate is the first listed.
NCT02283853 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02283853 about?
NCT02283853 is a clinical study titled "Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)". The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric participants with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and evolution of disability. The primary objective of Part 2 is to evaluate th...
What is the current status of trial NCT02283853?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2014-08-28. Estimated completion is 2025-07-08.
What interventions are being tested in trial NCT02283853?
The interventions under investigation include: dimethyl fumarate (DRUG), Interferon β-1a (DRUG).
Who is sponsoring clinical trial NCT02283853?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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