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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|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: BG00012||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Completion Date :||March 2006|
- The primary endpoint for the primary objective is the total number of MRI lesions at Weeks 12, 16, 20, and 24.
- 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.
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Must be 18 to 55 years old, inclusive, at the time of informed consent.
- Must have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 (McDonald et al, 2001; Appendix 2).
- 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.
- Primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996 [Appendix 3]).
- History of malignancy.
- History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
- 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.
- History of human immunodeficiency virus (HIV).
- History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization.
- 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.
- Body weight >100 kg.
- Positive for hepatitis C antibody and/or positive for hepatitis B surface antigen (HBsAg) at screening.
- Any of the following abnormal blood tests at screening.
- Any previous treatment with FUMADERM®, FAG-201, or BG00012.
- A medication history that precludes entry into the study.
- Female subjects who are currently pregnant or breast-feeding.
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
|Principal Investigator:||Ludwig Kappos, Prof||Kantonsspital Basel|
|Study Director:||Gilmore O'Neill, MB, MRCPI, MMedSc||Biogen|
|Other Study ID Numbers:||
|First Posted:||September 15, 2005 Key Record Dates|
|Last Update Posted:||November 15, 2007|
|Last Verified:||November 2007|
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases
Physiological Effects of Drugs