Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)

Biogen

Status and phase: Withdrawn; Phase 3

Conditions: Relapsing-Remitting Multiple Sclerosis; Relapsing Forms of Multiple Sclerosis

Treatments: Drug: Placebo; Drug: dimethyl fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT02428218

109MS309

2014-005624-98 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

BG00012

Experimental group

Description:

Participants will receive 120 mg capsule(s) BG00012 taken orally.

Treatment:

Drug: dimethyl fumarate

Placebo

Experimental group

Description:

Participants will receive matching placebo capsule(s) taken orally.

Treatment:

Drug: Placebo