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Efficacy and Safety of BG00012 in MS

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ClinicalTrials.gov Identifier: NCT00168701
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 15, 2007
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Brief Summary:
Determine the efficacy,safety, and tolerability of BG00012 in MS patients.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: BG00012 Phase 2

Detailed Description:
The study will be divided into two parts: Part 1 will be a 24-week, blinded, placebo-controlled treatment phase followed by Part 2, a 24-week blinded, safety extension phase in which all subjects will receive BG00012.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
Study Start Date : October 2004
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24.

Secondary Outcome Measures :
  1. The secondary endpoints will include measuring the changes in MRIs from baseline until Week 24, changes in other MS measurements q12 weeks, and the annualized relapse rate and proportion of changes at Weeks 24 and 48.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Must be 18 to 55 years old, inclusive, at the time of informed consent.
  2. Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2).
  3. Must have a baseline EDSS between 0.0 and 5.0, inclusive.

5. Must have experienced at least one relapse within the 12 months prior to randomization, with a prior cranial MRI demonstrating lesion(s) consistent with MS OR show evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks.

6. Male and female subjects must be willing to take appropriate measures to prevent pregnancy.

Exclusion Criteria:

  1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996 [Appendix 3]).
  2. History of malignancy.
  3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
  4. History of abnormal laboratory results indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurologic (other than MS), and/or other major disease.
  5. History of human immunodeficiency virus (HIV).
  6. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
  7. An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization.
  8. Body weight >100 kg.
  9. Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
  10. Any of the following abnormal blood tests at screening.
  11. Any previous treatment with FUMADERM®, FAG-201, or BG00012.
  12. A medication history that precludes entry into the study.
  13. Female subjects who are currently pregnant or breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168701

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Sponsors and Collaborators
Principal Investigator: Ludwig Kappos, Prof Kantonsspital Basel
Study Director: Gilmore O'Neill, MB, MRCPI, MMedSc Biogen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00168701     History of Changes
Other Study ID Numbers: C-1900
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 15, 2007
Last Verified: November 2007

Keywords provided by Biogen:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs