Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
Completed · Phase 3
Conditions studied: Relapsing-Remitting Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT02283853
- Run by
- Biogen
- People needed
- 156
- Starts
- 2014-08-28
- Expected to finish
- 2025-07-08
- Last updated by the study team
- 2026-05-19
Who can join
Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Rector and Visitors of the University of Virginia — Charlottesville, Virginia, United States
- Universitair Kinderziekenhuis Koningin Fabiola — Brussels, Belgium
- Universitair Ziekenhuis Ghent — Ghent, Belgium
- MHATNP 'Sv.Naum', EAD — Sofia, Bulgaria
- University of Calgary - Alberta Children's Hospital — Calgary, Alberta, Canada
- Fakultni nemocnice u sv. Anny v Brne — Brno, Czechia
- Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia
- Nemocnice Jihlava p.o. — Jihlava, Czechia
- Fakultni nemocnice Ostrava — Ostrava, Czechia
- Århus Universitetshospital — Aarhus N, Denmark
- Rigshospitalet — Copenhagen, Denmark
- Odense Universitetshospital — Odense, Denmark
- CHU Strasbourg - Hôpital Hautepierre — Strasbourg, Bas Rhin, France
- Hôpital de la Timone — Marseille, Bouches-du-Rhône, France
- CHU Dijon -BOCAGE CENTRAL — Dijon, Côte-d'Or, France
- Hopital Gui de Chauliac — Montpellier, Herault, France
- CHU Rennes - Hopital Pontchaillou — Rennes, Ille Et Vilaine, France
- Hôpital de Brabois Enfants — Vandœuvre-lès-Nancy, Meurthe Et Moselle, France
- Hopital Roger Salengro - CHU Lille — Lille, Nord, France
- CHU Clermont Ferrand - Hôpital d'Estaing — Clermont-Ferrand, Puy De Dome, France
- Hopital Neurologique Pierre Wertheimer — Bron, Rhone, France
- CHU Amiens - Hopital Sud — Amiens, Somme, France
- Hôpital Bicêtre — Le Kremlin-Bicêtre, Val De Marne, France
- Universitaetsklinikum Augsburg — Augsburg, Bavaria, Germany
- Boston Children's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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