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

April 11, 2016 updated by: Biogen

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BG00012
Participants will receive 120 mg capsule(s) BG00012 taken orally.
Drug: dimethyl fumarate
enteric-coated microtablets
Other Names:
  • BG00012
  • DMF
Experimental: Placebo
Participants will receive matching placebo capsule(s) taken orally.
Drug: Placebo
enteric-coated microtablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first multiple sclerosis (MS) relapse
Time Frame: 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.
Up to week 104

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

January 1, 2027

Study Completion (Anticipated)

January 1, 2027

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 11, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109MS309
  • 2014-005624-98 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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