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Efficacy and Safety of BG00012 in MS
This study has been completed.
First Received: September 9, 2005   Last Updated: November 14, 2007   History of Changes
Sponsor: Biogen Idec
Information provided by: Biogen Idec
ClinicalTrials.gov Identifier: NCT00168701
  Purpose

Determine the efficacy,safety, and tolerability of BG00012 in MS patients.


Condition Intervention Phase
Multiple Sclerosis
Drug: BG00012
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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
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 National Clinical Trials Identifier (NCT ID):
Study ID Numbers: C-1900
Study First Received: September 9, 2005
Last Updated: November 14, 2007
ClinicalTrials.gov Identifier: NCT00168701     History of Changes
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:
Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Nervous System Diseases
Dimethyl fumarate
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Immunosuppressive Agents
Pharmacologic Actions
Multiple Sclerosis
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Demyelinating Autoimmune Diseases, CNS
Dermatologic Agents
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on February 08, 2010