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Efficacy and Safety of BG00012 in MS

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168701
First Posted: September 15, 2005
Last Update Posted: November 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biogen
  Purpose
Determine the efficacy,safety, and tolerability of BG00012 in MS patients.

Condition Intervention Phase
Multiple Sclerosis Drug: BG00012 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Biogen:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 260
Study Start Date: October 2004
Study Completion Date: March 2006
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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.
  Contacts and Locations
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


  Show 42 Study Locations
Sponsors and Collaborators
Biogen
Investigators
Principal Investigator: Ludwig Kappos, Prof Kantonsspital Basel
Study Director: Gilmore O'Neill, MB, MRCPI, MMedSc Biogen
  More Information

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 Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: November 15, 2007
Last Verified: November 2007

Keywords provided by Biogen:
Multiple Sclerosis
MRI

Additional relevant MeSH terms:
Sclerosis
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