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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00420212
First received: January 8, 2007
Last updated: September 12, 2013
Last verified: May 2011

January 8, 2007
September 12, 2013
January 2007
February 2011   (final data collection date for primary outcome measure)
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 ]
To determine if BG00012 is effective in reducing the proportion of relapsing subjects at 2 years.
Complete list of historical versions of study NCT00420212 on ClinicalTrials.gov Archive Site
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 ]
There are multiple secondary outcomes.
Not Provided
Not Provided
 
Efficacy and Safety of Oral BG00012 in Relapsing-Remitting Multiple Sclerosis
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Relapsing-remitting Multiple Sclerosis
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: 1
    Intervention: Drug: BG00012
  • Experimental: 2
    Intervention: Drug: BG00012
  • Placebo Comparator: 3
    Intervention: Drug: BG00012

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1237
February 2011
February 2011   (final data collection date for primary outcome measure)

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.

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belarus,   Belgium,   Bosnia and Herzegovina,   Bulgaria,   Canada,   Croatia,   Czech Republic,   France,   Germany,   Greece,   Guatemala,   India,   Israel,   Italy,   Kazakhstan,   Macedonia, The Former Yugoslav Republic of,   Mexico,   Moldova, Republic of,   Netherlands,   New Zealand,   Poland,   Romania,   Serbia,   Slovakia,   South Africa,   Switzerland,   Turkey,   Ukraine,   United Kingdom,   Virgin Islands (U.S.)
 
NCT00420212
109MS301
Yes
Biogen Idec MD, Biogen Idec Inc.
Biogen Idec
Not Provided
Not Provided
Biogen Idec
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP