Indication
Secondary Progressive Multiple Sclerosis

Stage
Phase II/III

Location of Study
Canada and Europe
47 trial sites in 10 countries

Description
The trial is designed to evaluate the safety and efficacy of MBP8298 in patients with secondary progressive MS. The trial is a randomized, double-blind study with the primary clinical endpoint defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study.

In April 2007 the independent Data Safety Monitoring Board completed an interim safety analysis on the first 100 patients enrolled and recommended the trial continue per the protocol. The next interim analysis, targeted for mid-2008, will look at both safety and efficacy of the first 200 patients who have completed 24 months of the clinical trial. Full analysis is targeted for 2009.

Status
The trial is fully recruited. Thank you to all participating patients and investigators.