16th Meeting of the European Neurological Society
27.05.2006 - 31.05.2006
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Home - 30.05.2006 - Multiple sclerosis 4


Multiple sclerosis 4

Tuesday, May 30, 2006, 16:00 - 16:15

Efficacy of a novel oral single-agent fumarate, BG00012, in patients with relapsing-remitting multiple sclerosis: results of a phase 2 study

L. Kappos, D.H. Miller, D.G. MacManus, R. Gold, E. Havrdova, V. Limmroth, C. Polman, K. Schmierer, T. Yousry, M. Yang, M. Eraksoy, E. Meluzinova, I. Rektor, G.N. O'Neill (Basel, CH; London, GB; Gottingen, D; Prague, CZ; Cologne, D; Amsterdam, NL; Cambridge, USA; Istanbul, TR; Brno, CZ)

Objective: To determine the efficacy of three dose levels of BG00012, a novel oral fumarate preparation, on brain lesion activity as measured by magnetic resonance imaging (MRI) in patients with relapsing-remitting multiple sclerosis (RRMS).
Methods: This was a randomised, double-blind, placebo-controlled clinical trial of BG00012 in patients with RRMS. Men and women 18 to 55 years of age were eligible for the study if they had a diagnosis of RRMS and an Expanded Disability Status Scale (EDSS) score between 0.0 and 5.0. In addition, patients must have had either >=1 relapse within 12 months prior to randomisation or gadolinium-enhancing (Gd+) lesions on cranial MRI at screening. Patients were assigned to four treatment groups and received BG00012 capsules 120 mg by mouth (PO) once daily (120 mg/day), 120 mg three times daily (360 mg/day), 240 mg three times daily (720 mg/day), or placebo for 24 weeks. The treatment period was followed by a 24-week dose-blinded safety-extension period during which all patients received BG00012. The primary end point was the total number of Gd+ lesions over four MRI scans at weeks 12, 16, 20, and 24 (calculated as the sum of the four scans). Secondary end points included the cumulative number of new Gd+ lesions from week 4 to week 24 and the number of new/enlarging T2-hyperintense lesions at week 24. Additional end points included the number of new T1-hypointense lesions at week 24, relapse rate, and disability progression as measured by EDSS.
Results: A total of 257 patients were enrolled in the study; 64 patients each were randomly assigned to receive one of the three BG00012 doses and 65 patients to placebo. Approximately 90% of patients completed the 24-week treatment period. BG00012 (720 mg/day) significantly reduced the mean number of new Gd+ lesions (the primary end point) compared with placebo. In addition, BG00012 reduced the cumulative number of new Gd+ lesions, the number of new/enlarging T2-hyperintense lesions, and the number of new T1-hypointense lesions compared with placebo.
Conclusion: BG00012 significantly reduces brain lesion activity, in a dose-dependent manner, as measured by MRI in patients with RRMS over 24 weeks of treatment.