Update: Remyelination Clinical Trial
Mayo Clinic and Acorda Therapeutics, Inc. have been working together for more than ten years to explore the potential use of rHIgM22 (also known as Antibody 22) in multiple sclerosis (MS). In January 2013, the FDA gave its approval for a Phase 1 clinical trial enrolling people with MS to assess the safety and tolerability of rHIgM22. The study also includes several exploratory efficacy measures.
In preclinical studies, rHIgM22 has been shown to stimulate production of new myelin and improve function. It is the first drug that seeks to address the loss of myelin that can cause progressive functional impairment in people with MS.
The primary objective of this double-blind, randomized single ascending dose study is to evaluate the safety and tolerability of rHIgM22 in people with MS. The study also includes several exploratory efficacy measures, including magnetic resonance imaging and standard clinical measures used to assess people with MS, such as walking ability. Participants in the trial will receive either placebo or rHIgM22 administered as a single intravenous dose. If rHIgM22 is well tolerated in study groups receiving a low dose of rHIgM22, subsequent groups will receive single infusions of higher doses. Participants in this study will continue receiving their standard MS treatments.
Additional details on this clinical study, including enrollment criteria and contact information for study sites, can be found at: http://www.clinicaltrials.gov/ct2/show/NCT01803867?term=acorda&rank=12