Trials / Completed
CompletedNCT02555215
Extension Study of BG00012 in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)
A Multicenter Extension Study to Determine the Long-Term Safety and Efficacy of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Biogen · Industry
- Sex
- All
- Age
- 10 Years – 17 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dimethyl fumarate | administered orally |
Timeline
- Start date
- 2016-02-22
- Primary completion
- 2018-09-24
- Completion
- 2018-09-24
- First posted
- 2015-09-21
- Last updated
- 2019-11-22
- Results posted
- 2019-11-22
Locations
12 sites across 10 countries: United States, Belgium, Bulgaria, Czechia, Germany, Kuwait, Latvia, Lebanon, Poland, Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT02555215. Inclusion in this directory is not an endorsement.