Status:
COMPLETED
Efficacy and Safety of BG00012 in MS
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
Determine the efficacy, safety, and tolerability of BG00012 in MS patients.
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...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Male and female subjects must be willing to take appropriate measures to prevent pregnancy.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2006
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00168701
Start Date
October 1 2004
End Date
March 31 2006
Last Update
August 28 2023
Active Locations (42)
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1
Faculty Hospital St. Anne
Bmo, Czechia, 656 91
2
Faculty Hospital
Hradec Králové, Czechia, 500 05
3
Hospital of Pardubice
Pardupice, Czechia, 532 03
4
Faculty Hospital of Plzen
Pilsen, Czechia, 304 60