Retrospective Analysis of Diffusion Tensor Imaging from the SPRINT-MS Clinical Trial: Advancing Trial Methodology

Motivation: There are few treatment options for progressive multiple sclerosis (MS). Imaging biomarkers play an important role in clinical trials of treatment for relapsing-remitting MS, but imaging biomarkers with demonstrated usefulness in progressive MS are lacking. Goal(s): To identify potential imaging biomarkers for use in clinical trials of therapies for the progressive multiple sclerosis (MS). Approach: A retrospective analysis of diffusion tensor imaging (DTI) data from SPRINT-MS, a placebo-controlled phase 2 trial of Ibudilast for progressive MS was performed. Results: Radial diffusivity in cingulum and superior cerebellar peduncles was significantly different between treatment and placebo groups (p < 0.04). Impact: The cingulum and cerebellar peduncle are potential areas for focus in the evaluation of therapies in progressive MS.