Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-09-23

Brief Summary

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The primary objective of this study is to evaluate the effect of BG00012 (dimethyl fumarate) on brain magnetic resonance imaging (MRI) lesions in pediatric participants with relapsing-remitting multiple sclerosis (RRMS). The secondary objectives of this study are to characterize the pharmacokinetics of BG00012 in pediatric participants with RRMS and to evaluate the safety and tolerability of BG00012 in pediatric participants with RRMS.

Detailed Description

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Conditions

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Multiple Sclerosis, Relapsing-Remitting

Keywords

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Pediatrics

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BG00012

Oral BG00012 120 mg twice daily (BID) for the first 7 days followed by 240 mg BID for 24 weeks.

Group Type EXPERIMENTAL

dimethyl fumarate

Intervention Type DRUG

Interventions

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dimethyl fumarate

Intervention Type DRUG

Other Intervention Names

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BG00012 DMF

Eligibility Criteria

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Inclusion Criteria

* Ability of parents or legal guardians to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parent or legal guardian, as appropriate, as per local regulations.
* Must have a body weight of ≥30 kg at Screening and Day 1.
* Must have a diagnosis of RRMS according to McDonald criteria for MS (2010) \[Polman 2011\] and International Pediatric Multiple Sclerosis (MS) Study Group criteria for pediatric MS (2013) \[Krupp 2013\].

Exclusion Criteria

* Primary progressive, secondary progressive, or progressive relapsing MS (as defined by \[Lublin and Reingold 1996\]). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement.
* Disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease, lupus erythematosus, and neuromyelitis optica), metabolic disorders (e.g., dystrophies), and infectious disorders.
* History of severe allergic or anaphylactic reactions or known drug hypersensitivity to dimethyl fumarate or fumaric acid esters.

Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

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Alroughani R, Das R, Penner N, Pultz J, Taylor C, Eraly S. Safety and Efficacy of Delayed-Release Dimethyl Fumarate in Pediatric Patients With Relapsing Multiple Sclerosis (FOCUS). Pediatr Neurol. 2018 Jun;83:19-24. doi: 10.1016/j.pediatrneurol.2018.03.007. Epub 2018 Mar 22.

Reference Type DERIVED

PMID: 29681490 (View on PubMed)

Other Identifiers

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2014-005003-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

109MS202

Identifier Type: -

Identifier Source: org_study_id

Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMS

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

BG00012

dimethyl fumarate

Interventions

dimethyl fumarate

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Biogen

Responsible Party

Principal Investigators

Medical Director

Locations

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Countries

References

Alroughani R, Das R, Penner N, Pultz J, Taylor C, Eraly S. Safety and Efficacy of Delayed-Release Dimethyl Fumarate in Pediatric Patients With Relapsing Multiple Sclerosis (FOCUS). Pediatr Neurol. 2018 Jun;83:19-24. doi: 10.1016/j.pediatrneurol.2018.03.007. Epub 2018 Mar 22.

Other Identifiers

2014-005003-24

109MS202