Back to resultsPlacebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
Primary Purpose
Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
dimethyl fumarate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring Randomized, Ages 10-17, Pediatrics, Placebo controlled, Relapse-Remitting, Multiple Sclerosis, Safety, Efficacy, BG00012
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BG00012
Placebo
Arm Description
Participants will receive 120 mg capsule(s) BG00012 taken orally.
Participants will receive matching placebo capsule(s) taken orally.
Outcomes
Primary Outcome Measures
Time to first multiple sclerosis (MS) relapse
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 Outcome Measures
Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)
Number of new or newly enlarging T2 Hyperintense Lesions on Brain magnetic resonance imaging (MRI) scans
Number of gadolinium-enhancing Lesions
Annualized MS relapse rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02428218
Brief Title
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Feasibility
Study Start Date
May 2016 (undefined)
Primary Completion Date
January 2027 (Anticipated)
Study Completion Date
January 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Keywords
Randomized, Ages 10-17, Pediatrics, Placebo controlled, Relapse-Remitting, Multiple Sclerosis, Safety, Efficacy, BG00012
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BG00012
Arm Type
Experimental
Arm Description
Participants will receive 120 mg capsule(s) BG00012 taken orally.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Participants will receive matching placebo capsule(s) taken orally.
Intervention Type
Drug
Intervention Name(s)
dimethyl fumarate
Other Intervention Name(s)
BG00012, DMF
Intervention Description
enteric-coated microtablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
enteric-coated microtablets
Primary Outcome Measure Information:
Title
Time to first multiple sclerosis (MS) relapse
Description
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.
Time Frame
Up to week 104
Secondary Outcome Measure Information:
Title
Number of participants that experience adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Up to week 104
Title
Number of new or newly enlarging T2 Hyperintense Lesions on Brain magnetic resonance imaging (MRI) scans
Time Frame
Weeks 24, 48, 72 and 96
Title
Number of gadolinium-enhancing Lesions
Time Frame
Baseline, and weeks 24, 48, 72 and 96
Title
Annualized MS relapse rate
Time Frame
weeks 48 and 96
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
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