NCT02428218

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
8mo left

Started May 2016

Longer than P75 for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
May 2016Jan 2027

First Submitted

Initial submission to the registry

April 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2015

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

April 13, 2016

Status Verified

April 1, 2016

Enrollment Period

10.7 years

First QC Date

April 23, 2015

Last Update Submit

April 11, 2016

Conditions

Relapsing-Remitting Multiple SclerosisRelapsing Forms of Multiple Sclerosis

Keywords

RandomizedAges 10-17PediatricsPlacebo controlledRelapse-RemittingMultiple SclerosisSafetyEfficacyBG00012

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to week 104

Secondary Outcomes (4)

  • 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

Study Arms (2)

BG00012

EXPERIMENTAL

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

Drug: dimethyl fumarate

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

dimethyl fumarateDRUG

enteric-coated microtablets

Also known as: BG00012, DMF
BG00012
PlaceboDRUG

enteric-coated microtablets

Placebo

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

FumaratesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

April 28, 2015

Study Start

May 1, 2016

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

April 13, 2016

Record last verified: 2016-04