Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis (DEFINE)

This study has been completed.
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
First received: January 8, 2007
Last updated: September 12, 2013
Last verified: May 2011

To determine if treatment with BG00012 can decrease the number of MS relapses during a certain time period. To determine if, over time, BG00012 treatment can decrease the number of certain types of brain lesions commonly seen in MS patients and slow down the time it takes for the disease to get worse.

The purpose of this study is also to determine the safety of BG00012 and how well it is tolerated. Another goal is to see what effect BG00012 may have on tests and evaluations used to assess MS.

Condition Intervention Phase
Relapsing-remitting Multiple Sclerosis
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 Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To determine if BG00012 is effective in reducing the proportion of relapsing subjects at 2 years. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine if BG00012 decreases the number of brain lesions and slows time to progression. To determine the safety and tolerability of BG00012, and the effect it may have on tests and evaluations used to assess MS. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 1237
Study Start Date: January 2007
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: BG00012
240 mg (two 120 mg capsules) orally twice a day, 240 mg (two 120 mg capsules) orally three times a day. 2-year study
Experimental: 2 Drug: BG00012
240 mg (two 120 mg capsules) orally twice a day, 240 mg (two 120 mg capsules) orally three times a day. 2-year study
Placebo Comparator: 3 Drug: BG00012
240 mg (two 120 mg capsules) orally twice a day, 240 mg (two 120 mg capsules) orally three times a day. 2-year study


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

Inclusion Criteria:

  • Unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization:
  • Aged 18 to 55 years old, inclusive, at the time of informed consent.
  • Must have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
  • Must have a baseline EDSS between 0.0 and 5.0, inclusive.
  • Must have relapsing-remitting disease course.

Exclusion Criteria:

  • Unless otherwise specified, candidates will be excluded from study entry if any of the following exclusion criteria exist at randomization:
  • 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: NCT00420212

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Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided by Biogen Idec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen Idec MD, Biogen Idec Inc.
ClinicalTrials.gov Identifier: NCT00420212     History of Changes
Other Study ID Numbers: 109MS301
Study First Received: January 8, 2007
Last Updated: September 12, 2013
Health Authority: Romania: National Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Israel: Ethics Commission
Ukraine: State Pharmacological Center - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Mexico: Federal Commission for Protection Against Health Risks
Guatemala: Ministerio de Salud Publica y Asistencia Social
Australia: Department of Health and Ageing Therapeutic Goods Administration
India: Ministry of Health
South Africa: Department of Health
United States: Institutional Review Board
Austria: Agency for Health and Food Safety
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Greece: National Organization of Medicines
Sweden: Medical Products Agency
Slovakia: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Croatia: Ministry of Health and Social Care
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United States: Food and Drug Administration
Turkey: Ministry of Health
Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by Biogen Idec:
multiple sclerosis

Additional relevant MeSH terms:
Multiple 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 April 17, 2014