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An Efficacy and Safety Study of BG00012 (Dimethyl Fumarate) in Asian Subjects With Relapsing Remitting Multiple Sclerosis (RRMS)

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ClinicalTrials.gov Identifier: NCT01838668
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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Brief Summary:

This is a multicenter study conducted in 2 parts:

The primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS) including participants from the Asia-Pacific region.

The secondary objectives in Part I of this study in this study population are to determine whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24 compared with Baseline.

The primary objective in Part II (open label) of this study is to evaluate the long-term safety profile of BG00012 in eligible participants from Part I.


Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Multiple Sclerosis Drug: Placebo Drug: dimethyl fumarate Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of BG00012 in Subjects From the Asia-Pacific Region and Other Countries With Relapsing-Remitting Multiple Sclerosis
Actual Study Start Date : March 28, 2013
Actual Primary Completion Date : June 16, 2015
Actual Study Completion Date : September 4, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Part I Placebo

Placebo orally twice a day. In Part I: participants will be randomized into one of 2 groups: BG00012, 240 mg twice daily (BID) or matching placebo BID

Participants will begin the study by taking 1 capsule orally BID for first 7 days and escalate their dosing from day 8 to 2 matching capsules orally BID.

 Drug: Placebo
Two placebo capsules orally BID
Experimental: Part I BG00012
BG00012 240 mg orally twice a day (participants will begin dosing at 120 mg BG00012 twice daily (BID) for the first 7 days and 240 mg BG00012 BID thereafter.) In Part I: participants will be randomized into one of 2 groups: BG00012, 240 mg twice daily (BID) or matching placebo BID
 Drug: dimethyl fumarate
Two dimethyl fumarate 120mg capsules orally BID
Other Names:
  • BG00012
  • Tecfidera
  • DMF
Experimental: Part II BG00012
Part II: All participants will receive BG00012 240 mg orally twice a day (participants will begin dosing at 120 mg (1 capsule) BG00012 twice daily (BID) for the first 7 days and 240 mg (2 capsules) BG00012 BID thereafter.
 Drug: dimethyl fumarate
Two dimethyl fumarate 120mg capsules orally BID
Other Names:
  • BG00012
  • Tecfidera
  • DMF


Outcome Measures
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Primary Outcome Measures :
  1. Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24. [ Time Frame: Part I (Week 24) ]
  2. Incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: Part II (Up to 4.5 years) ]

Secondary Outcome Measures :
  1. Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24 [ Time Frame: Part I (Week 24) ]
  2. Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline [ Time Frame: Part I (Week 24) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Inclusion Criteria for Part I:

    • Must have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS).
    • Must have a baseline Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0, inclusive.

Key Inclusion Criteria for Part II:

• Subjects who participated in and completed Part I per protocol.

Key Exclusion Criteria:

  • Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
  • Pregnant or nursing women.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838668


Locations
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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01838668    
Other Study ID Numbers: 109MS305
2013-004533-32 ( EudraCT Number )
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs