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Efficacy and Safety of BG00012 in MS

Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis
CompletedPhase 2Relapsing MSNCT001687012004-000663-99

What it found

Met its main goal

The main measure showed a statistically significant benefit.

“Treatment with BG00012 240 mg three times daily reduced by 69% the mean total number of new GdE lesions from week 12 to 24 compared with placebo (1.4 vs 4.5, p<0.0001).”
Read by software from the paper's abstract

total number of new gadolinium enhancing (GdE) lesions on brain MRI scans at weeks 12, 16, 20, and 24

GroupnValue
BG00012 240 mg three times daily641.4
Placebo654.5

reduction in mean total number of new GdE lesions vs placebo 69%

p = <0.0001

Total participants: 257

Read by software from the paper's abstract

What was tested

Treatment tested

What it measured

Main measures

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

    Weeks 12, 16, 20, and 24

    MRI lesions

  • The primary endpoint is the total number of Gd-enhancing lesions over four scans at Weeks 12,16,20 and 24 (calculated as the sum of these four MRI scans).

    MRI lesions

Other measures (1)

  • 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.

    Weeks 24 and 48

    Relapses

Who could take part

Relapsing MS · 18 to 55

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. 4. 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. 5. 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

Papers

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History

    1. Started

      Oct 2004

    2. Main results due

      Mar 2006

    3. Finished

      Mar 2006

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