A safety and efficacy study of BG00012 in slowing the progression of disability in Pediatric patients with Relapsing -Remitting Multiple Sclerosis.
- Conditions
- Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple SclerosisMedDRA version: 18.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 18.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-005624-98-HU
- Lead Sponsor
- Biogen Idec Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 172
Key Inclusion Criteria:
- Informed consent and assent as appropriate
- Must have a body weight of =30 kg
- Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric multiple sclerosis (MS)
- Must be ambulatory with a converted Krutzke Baseline Expanded Disability Status Scale (EDSS) score between 0 and 5.0, inclusive
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Are the trial subjects under 18? yes
Number of subjects for this age range: 172
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Key Exclusion Criteria:
- Primary progressive, secondary progressive, or progressive relapsing MS.
- History of disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease and lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.
- History of severe allergic or anaphylactic reactions, or known drug hypersensitivity to dimethyl fumarate (DMF) or fumaric acid esters.
- Prior treatment with any of the following medications within 12 months prior to randomization: mitoxantrone, cyclophosphamide, rituximab.
- Prior treatment with any of the following medications or procedures within 6 months prior to randomization: fingolimod, teriflunomide, natalizumab, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, laquinimod, intravenous (IV) immunoglobulin, plasmapheresis or cytapheresis.
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the study is to assess the efficacy of BID oral BG00012 as compared with placebo in pediatric subjects with RRMS.;Secondary Objective: The secondary objectives of this study are as follows:<br>-To evaluate the safety and tolerability of BG00012.<br>-To compare the effect of BG00012 with placebo on additional clinical and radiological measures of disease activity.;Primary end point(s): Time to first multiple sclerosis (MS) relapse<br>-Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist.;Timepoint(s) of evaluation of this end point: Time to first multiple sclerosis (MS) relapse<br>up to week 104
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)<br>2. Number of new or newly enlarging T2 Hyperintense Lesions on Brain magnetic resonance imaging (MRI) scans<br>3. Number of gadolinium-enhancing Lesions<br>4. Annualized MS relapse rate;Timepoint(s) of evaluation of this end point: For secondary endpoints 1,2 ,3 and 4 above timepoints are as follows:<br>1.up to week 104<br>2.Weeks 24, 48, 72 and 96<br>3.Baseline, and weeks 24, 48, 72 and 96<br>4.weeks 48 and 96