Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)

PHASE3CompletedINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

August 28, 2014

Primary Completion Date

July 8, 2025

Study Completion Date

July 8, 2025

Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
DRUG

dimethyl fumarate

administered orally

DRUG

Interferon β-1a

administered by intramuscular injection

Trial Locations (62)

1020

Universitair Kinderziekenhuis Koningin Fabiola, Brussels

1083

Semmelweis Egyetem, Budapest

1089

Heim Pal Orszagos Gyermekgyogyaszati Intezet, Budapest

1113

MHATNP 'Sv.Naum', EAD, Sofia

2100

Rigshospitalet, Copenhagen

2115

Boston Children's Hospital, Boston

5000

Odense Universitetshospital, Odense

8200

Århus Universitetshospital, Aarhus N

8950

Hospital Sant Joan de Deu, Esplugues de Llobregat

9000

Universitair Ziekenhuis Ghent, Ghent

11000

Clinic of Neurology and Psychiatry for Children and Youth, Belgrade

Mother and Child Health Care Institute of Serbia ,,Dr Vukan Cupic'', Belgrade

12345

Ibn Sina Hospital, Ash Shuwaykh

13385

Hôpital de la Timone, Marseille

14011

Hospital Universitario Reina Sofia, Córdoba

16132

IRCCS Ospedale Policlinico San Martino, Genova

20132

Ospedale San Raffaele, Milan

21013

Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate), Gallarate

21079

CHU Dijon -BOCAGE CENTRAL, Dijon

22903

The Rector and Visitors of the University of Virginia, Charlottesville

28850

Hospital Universitario de Torrejon, Torrejón de Ardoz

34000

University Clinical Center Kragujevac, Kragujevac

34295

Hopital Gui de Chauliac, Montpellier

35033

CHU Rennes - Hopital Pontchaillou, Rennes

35128

Azienda Ospedale-Università di Padova, Padua

41009

Hospital Universitario Virgen Macarena, Seville

41345

Sahlgrenska Sjukhuset, Gothenburg

44791

Katholisches Klinikum Bochum gGmbH, Bochum

54500

Hôpital de Brabois Enfants, Vandœuvre-lès-Nancy

58633

Nemocnice Jihlava p.o., Jihlava

59037

Hopital Roger Salengro - CHU Lille, Lille

63003

CHU Clermont Ferrand - Hôpital d'Estaing, Clermont-Ferrand

67098

CHU Strasbourg - Hôpital Hautepierre, Strasbourg

69677

Hopital Neurologique Pierre Wertheimer, Bron

70124

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari, Bari

80054

CHU Amiens - Hopital Sud, Amiens

80131

Azienda Ospedaliera Universitaria 'Federico II', Napoli

80337

Klinikum der Universitaet Muenchen, Munich

86156

Universitaetsklinikum Augsburg, Augsburg

90127

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo

91120

Hadassah University Hospital - Ein Kerem, Jerusalem

94275

Hôpital Bicêtre, Le Kremlin-Bicêtre

4920235

Schneider Children's Medical Center, Petah Tikva

5265601

Chaim Sheba Medical Center, Ramat Gan

T3B 6A8

University of Calgary - Alberta Children's Hospital, Calgary

656 91

Fakultni nemocnice u sv. Anny v Brne, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

708 52

Fakultni nemocnice Ostrava, Ostrava

00165

Ospedale Pediatrico Bambino Gesù, Roma

00189

Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza, Roma

15-274

SPZOZ Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa, Bialystok

80-211

Uniwersyteckie Centrum Kliniczne, Gdansk

93-338

Instytut Centrum Zdrowia Matki Polki, Lodz

60-355

Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu, Poznan

04-730

Instytut 'Pomnik - Centrum Zdrowia Dziecka', Warsaw

SE-113 61

Karolinska, Stockholm

06100

Hacettepe University Medical Faculty, Ankara

07070

Akdeniz University Faculty of Medicine, Antalya

SE1 7EH

Evelina London Children's Hospital, London

WC1N 3BG

The National Hospital for Neurology & Neurosurgery, London

WC1N 3JH

Great Ormond Street Hospital for Children, London

B4 6NH

Birmingham Children's Hospital, Birmingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Biogen

INDUSTRY

NCT02283853 - Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) | Biotech Hunter | Biotech Hunter