Clinical trial NCT02428218: Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
Official title: A Randomized, Placebo-Controlled, Parallel-Group Study in Pediatric Subjects Ages 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 for the Treatment of Relapsing-Remitting Forms of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Relapsing-Remitting Multiple Sclerosis
Relapsing Forms of Multiple Sclerosis
Keywords: Randomized
Ages 10-17
Pediatrics
Placebo controlled
Relapse-Remitting
Multiple Sclerosis
Safety
Efficacy
BG00012
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the efficacy of oral BG00012 as compared with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to evaluate the safety and tolerability of BG00012 and to compare the effect of BG00012 with placebo on additional clinical and radiological measures of disease activity.


Eligibility criteria: 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

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.

Primary outcomes:
measure: Time to first multiple sclerosis (MS) relapse
timeFrame: Up to week 104
Secondary outcomes:
measure: Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Up to week 104
measure: Number of new or newly enlarging T2 Hyperintense Lesions on Brain magnetic resonance imaging (MRI) scans
timeFrame: Weeks 24, 48, 72 and 96
measure: Number of gadolinium-enhancing Lesions
timeFrame: Baseline, and weeks 24, 48, 72 and 96
measure: Annualized MS relapse rate
timeFrame: weeks 48 and 96
Other outcomes:
Locations:
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: