Indication
Secondary Progressive Multiple Sclerosis (SPMS)
Stage
Phase III
Location of Study
United States
68 trial sites
Description
The pivotal phase III clinical trial in the US will be evaluating dirucotide for the treatment of secondary progressive MS. This trial is a randomized, double-blind study enrolling approximately 510 patients who will be administered either dirucotide or placebo intravenously every six months for a period of two years.
The primary clinical endpoint for the trial is 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 (up to 70% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).
Status
This trial is fully recruited. Thank you to all participating patients and investigators.