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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01838668
First received: April 20, 2013
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Drug: Placebo
Drug: BG00012 (dimethyl fumarate)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Total number of new Gadolinium-enhancing lesions over 4 scans at Weeks 12, 16, 20, and 24. [ Time Frame: Part I (Week 24) ] [ Designated as safety issue: No ]
  • Incidence of treatment-emergent adverse events and serious adverse events [ Time Frame: Part II (Up to 4.5 years) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24 [ Time Frame: Part I (Week 24) ] [ Designated as safety issue: No ]
  • Number of new or newly enlarging T2 hyperintense lesions at Week 24 compared with Baseline [ Time Frame: Part I (Week 24) ] [ Designated as safety issue: No ]

Estimated Enrollment: 202
Study Start Date: March 2013
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Placebo
Placebo orally twice a day.
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: BG00012 (dimethyl fumarate)
BG00012 120 mg capsules.
Other Names:
  • DMF
  • dimethyl fumarate
Experimental: Part II BG00012
Part II: All participants will receive 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.)
Drug: BG00012 (dimethyl fumarate)
BG00012 120 mg capsules.
Other Names:
  • DMF
  • dimethyl fumarate

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01838668

Contacts
Contact: Biogen-Idec Investigator neurologyclinicaltrials@biogenidec.com

  Show 58 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01838668     History of Changes
Other Study ID Numbers: 109MS305, 2013-004533-32
Study First Received: April 20, 2013
Last Updated: August 18, 2014
Health Authority: Korea: Ministry of Food and Drug Safety
Taiwan: Department of Health
Czech Republic: State Institute for Drug Control
Japan: Pharmaceuticals and Medical Devices Agency (PMDA)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Dimethyl fumarate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 22, 2014