MedicalResearch.com Interview with:
Robert J. Fox, MD, FAAN
Principal Investigator | SPRINT-MS Trial
Mellen Center for MS | Cleveland Clinic
Cleveland, OH 44195
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The current treatment options for progressive multiple sclerosis are very limited. The SPRINT-MS trial sought to obtain proof-of-concept evidence that ibudilast has beneficial activity in progressive multiple sclerosis. In a placebo-controlled, 96-week trial of 255 people living with progressive MS, treatment with ibudilast slowed the progression of brain atrophy (brain shrinkage) by 48% compared to placebo. Side-effects of ibudilast included gastrointestinal symptoms, headache, and depression.
MedicalResearch.com: What should readers take away from your report?
Response: The SPRINT-MS trial provides evidence of beneficial activity of ibudilast in progressive multiple sclerosis as measured by slowed progression of brain atrophy. Whether this slowing in progression of brain atrophy will translate into slower progression in clinical disability remains unknown.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: The results from this trial provide the proof-of-concept evidence to support a larger, phase 3 trial evaluating the effect of ibudilast on progression of clinical disability in progressive multiple sclerosis.
MedicalResearch.com: Is there anything else you would like to add?
Response: The SPRINT-MS trial also evaluated the utility of other imaging measures of brain injury in progressive MS. The results of these other measures pointed towards cortical atrophy, which is shrinkage of the outermost layer of brain – where a significant amount of brain processing occurs, to be a sensitive measure of tissue injury and potential treatment response. Further studies will evaluate the utility of cortical atrophy as a more sensitive and robust metric of neuroprotection in progressive multiple sclerosis.
Disclosures: I have no disclosures relevant to this study.
Phase 2 Trial of Ibudilast in Progressive Multiple Sclerosis
Robert J. Fox, M.D., Christopher S. Coffey, Ph.D., Robin Conwit, M.D., Merit E. Cudkowicz, M.D., Trevis Gleason, B.S., Andrew Goodman, M.D., Eric C. Klawiter, M.D., Kazuko Matsuda, M.D., Michelle McGovern, B.S., Robert T. Naismith, M.D., Akshata Ashokkumar, M.S., Janel Barnes, Ph.D., et al., for the NN102/SPRINT-MS Trial Investigators*
August 30, 2018
N Engl J Med 2018; 379:846-855
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