109MS306, Paediatric Relapsing MS (10 - <18 years), BG00012
Research type
Research Study
Full title
Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension
IRAS ID
152754
Contact name
Evangeline Wassmer
Contact email
Sponsor organisation
Biogen Idec Research Limited
Eudract number
2013-002318-11
ISRCTN Number
NA
Clinicaltrials.gov Identifier
NA
Research summary
The main purpose of this study is to find out about the safety and effectiveness of BG00012 in paediatric patients (aged from 10 up to 18 years old) with relapsing remitting multiple sclerosis (RRMS). In this study, BG00012 is compared to another drug called Interferon â-1a (Avonex®). This study is Open-label, which means that both the patients and investigators/ site study team will know which treatment the patient is receiving. BG00012 is administered orally (capsule twice a day) and Interferon â-1a is administered by injection (once per week).
BG00012 (trade name Tecfidera™) is approved in USA, Canada, the European Union and Australia for the treatment of adult patients with RRMS and this study will help gather information about whether BG00012 is also suitable for paediatric patients. BG00012 is designed to reduce inflammation and protects nerve cells from damage caused by an immune attack.
Around 142 children and adolescents, in about 50 study centres in 15 countries, will take part in this study.
Patients are expected to received treatment for 96 weeks. Following completion of this study, the patients will have the option to enroll into an extension study where all patients will receive BG00012 capsules (separate protocol to be released). The Safety Follow-Up Visit will be conducted 4 weeks after the last study visit, for patients who do not continue in the extension study and for those who withdraw prematurely.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
14/EM/0203
Date of REC Opinion
8 Jul 2014
REC opinion
Further Information Favourable Opinion