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

This study is currently recruiting participants.
Verified May 2013 by Biogen Idec
Sponsor:
Collaborator:
Biogen Idec Research Ltd.
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01838668
First received: April 20, 2013
Last updated: May 2, 2013
Last verified: May 2013
  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 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 Asian subjects with Relapsing Remitting Multiple Sclerosis (RRMS). 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 subjects from Part I.


Condition Intervention Phase
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Drug: Placebo
Drug: BG00012
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 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: March 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Part I Placebo
Part I Placebo orally twice a day
Drug: Placebo
Placebo orally twice a day
Experimental: Part I BG00012
Part I BG00012 240mg orally twice a day
Drug: BG00012
BG00012 240mg orally twice a day
Experimental: Part II BG00012
Part II BG00012 240mg orally twice a day
Drug: BG00012
BG00012 240mg orally twice a day

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

Inclusion Criteria for Part II:

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

Exclusion Criteria:

  • Other chronic disease of the immune system, malignancies, acute urologic, pulmonary, gastrointestinal disease.
  • Pregnant or nursing women.
  • Other protocol-defined inclusion/exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01838668

Contacts
Contact: Biogen Idec neurologyclinicaltrials@biogenidec.com

Locations
Japan
Research Site Recruiting
Tokyo, Japan
Sponsors and Collaborators
Biogen Idec
Biogen Idec Research Ltd.
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01838668     History of Changes
Other Study ID Numbers: 109MS305
Study First Received: April 20, 2013
Last Updated: May 2, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
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 April 15, 2014