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

Sponsored by:	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 III

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	1011
Study Start Date:	January 2007
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: BG00012 240 mg (two 120 mg capsules) orally twice a day, 240 mg (two 240 mg capsules) orally three times a day. 2-year study
2: Experimental	Drug: BG00012 240 mg (two 120 mg capsules) orally twice a day, 240 mg (two 240 mg capsules) orally three times a day. 2-year study
3: Placebo Comparator	Drug: BG00012 240 mg (two 120 mg capsules) orally twice a day, 240 mg (two 240 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

Contacts

Contact: Biogen Idec Inc.		bg12studies@biogenidec.com
Contact: for more information visit www.msclinicalstudies.com

Show 169 Study Locations

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Biogen Idec Inc., MD

Biogen Idec

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Biogen Idec Inc. ( Biogen Idec MD )
Study ID Numbers:	109MS301
Study First Received:	January 8, 2007
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00420212
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; Austria: Agency for Health and Food Safety; Belgium: Directorate general for the protection of Public health: Medicines; Canada: Health Canada; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Organization of Medicines; Guatemala: Ministerio de Salud Publica y Asistencia Social; India: Ministry of Health; Israel: Ethics Commission; Mexico: Federal Commission for Protection Against Health Risks; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); New Zealand: Medsafe; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Romania: National Medicines Agency; Slovakia: State Institute for Drug Control; South Africa: Department of Health; Sweden: Medical Products Agency; Turkey: Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Biogen Idec:

multiple sclerosis
relapsing
remitting
oral

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes
Immune System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009