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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 April 2016
• Main ID: NCT02428218
• Date of registration: 23/04/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
• Scientific 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
• Date of first enrolment: May 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02428218
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & 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.



Age minimum: 10 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Relapsing Forms of Multiple Sclerosis

Relapsing-Remitting Multiple Sclerosis

Intervention(s)

Drug: Placebo

Drug: dimethyl fumarate

Primary Outcome(s)

Time to first multiple sclerosis (MS) relapse [Time Frame: Up to week 104]

Secondary Outcome(s)

Number of new or newly enlarging T2 Hyperintense Lesions on Brain magnetic resonance imaging (MRI) scans [Time Frame: Weeks 24, 48, 72 and 96]

Number of participants that experience adverse events (AEs) and serious adverse events (SAEs) [Time Frame: Up to week 104]

Annualized MS relapse rate [Time Frame: weeks 48 and 96]

Number of gadolinium-enhancing Lesions [Time Frame: Baseline, and weeks 24, 48, 72 and 96]

Secondary ID(s)

2014-005624-98

109MS309

Source(s) of Monetary Support

Please refer to primary and secondary sponsors