Efficacy and Safety of BG00012 in MS

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00168701
First received: September 9, 2005
Last updated: November 14, 2007
Last verified: November 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 Idec:

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168701

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

No publications provided by Biogen Idec

Additional 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
Study First Received: September 9, 2005
Last Updated: November 14, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board (MEB)
Czech Republic: State Institute for Drug Control
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Switzerland: Swissmedic
Turkey: Ministry of Health
Sweden: Medical Products Agency
Russia: Pharmacological Committee, Ministry of Health

Keywords provided by Biogen Idec:
Multiple Sclerosis
MRI

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 August 28, 2014