Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Multiple Sclerosis, Relapsing-Remitting
In brief
The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS. The other objectives of this study are to evaluate the safety and tolerability of dimethyl fumarate and peginterferon beta-1a and to assess the effect of dimethyl fumarate and peginterferon beta-1a, both compared with placebo, on additional clinical and radiological measures of disease activity.
Key facts
- Study ID
- NCT03870763
- Run by
- Biogen
- People needed
- 11
- Starts
- 2019-03-19
- Expected to finish
- 2022-07-21
- Last updated by the study team
- 2023-06-15
Who can join
Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Research Site — Raleigh, North Carolina, United States
- Research Site — Medellín, Colombia
- Research Site — Tallinn, Estonia
- Research Site — Budapest, Hungary
- Research Site — Ar Ramtha, Jordan
- Research Site — Petaling Jaya, Malaysia
- Research Site — Seberang Jaya, Malaysia
- Research Site — Guadalajara, Mexico
- Research Site — Morelia, Mexico
- Research Site — Santa Cruz, Mexico
- Research Site — Dammam, Saudi Arabia
- Research Site — Riyadh, Saudi Arabia
- Research Site — Seoul, South Korea
- Research Site — Taipei, Taiwan
- Research Site — Taoyuan, Taiwan
- Research Site — Bangkok, Thailand
- Research Site — Manouba, Tunisia
- Research Site — Monastir, Tunisia
- Research Site — Sfax, Tunisia
- Research Site — Tunis, Tunisia
- Research Site — Ankara, Turkey (Türkiye)
- Research Site — Izmir, Turkey (Türkiye)
- Research Site — Samsun, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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