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: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: 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-IT
- 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: 1
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<br>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<br>serious adverse events (SAEs)<br>2. Number of new or newly enlarging T2 Hyperintense Lesions on Brain<br>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