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

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

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02428218

Enrollment

Registered

2015-04-28

Start date

2016-05-31

Completion date

2027-01-31

Last updated

2016-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Forms of Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis

Keywords

Randomized, Ages 10-17, Pediatrics, Placebo controlled, Relapse-Remitting, Multiple Sclerosis, Safety, Efficacy, BG00012

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.

Interventions

DRUGdimethyl fumarate

enteric-coated microtablets

DRUGPlacebo

enteric-coated microtablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

10 Years to 17 Years

Healthy volunteers

Inclusion 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/

Design outcomes

Primary

Measure	Time frame	Description
Time to first multiple sclerosis (MS) relapse	Up to week 104	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.

Secondary

Measure	Time frame
Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)	Up to week 104
Number of new or newly enlarging T2 Hyperintense Lesions on Brain magnetic resonance imaging (MRI) scans	Weeks 24, 48, 72 and 96
Number of gadolinium-enhancing Lesions	Baseline, and weeks 24, 48, 72 and 96
Annualized MS relapse rate	weeks 48 and 96

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026