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

NCT ID: NCT02428218

Last Updated: 2016-04-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2027-01-31

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.

Conditions

Relapsing-Remitting Multiple Sclerosis; Relapsing Forms of Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BG00012

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

Group Type: EXPERIMENTAL

dimethyl fumarate

Intervention Type: DRUG

enteric-coated microtablets

Placebo

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

enteric-coated microtablets

Interventions

dimethyl fumarate

enteric-coated microtablets

Intervention Type: DRUG

Placebo

enteric-coated microtablets

Intervention Type: DRUG

Other Intervention Names

BG00012; DMF

Eligibility Criteria

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

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Biogen

Other Identifiers

2014-005624-98

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

109MS309

Identifier Type: -

Identifier Source: org_study_id