Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis - Full Text View

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00420212

Purpose

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:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

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

Eligibility

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

Criteria

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

Show 169 Study Locations

Sponsors and Collaborators

Biogen Idec

More Information

No publications provided

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:	May 12, 2011
Health Authority:	Romania: National Medicines Agency France: Afssaps - French Health Products Safety Agency 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: Directorate general for the protection of Public health: Medicines

Keywords provided by Biogen Idec:

relapsing
oral
remitting
multiple sclerosis

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 May 22, 2012