Cleveland Clinic Lou Ruvo Center for Brain Health is now recruiting participants for a new, relapsing-remitting multiple sclerosis treatment trial, DELIVER-MS. The purpose of the global, multi-center study, led by Cleveland Clinic, is to compare the benefits and risks of two common treatment approaches for multiple sclerosis to determine which is the better course. The first option uses a highly-effective treatment early in the disease state whereas the second is a more standard escalation approach, which uses moderately effective medications and escalates as needed. This is the first time the two approaches have been compared in a head-to-head trial.
“Patients and their doctors are faced with the dilemma of adopting one of two treatment approaches when managing relapsing-remitting multiple sclerosis. Both options have their share of risks and benefits, and we’re hoping that our research findings will illuminate the most beneficial choice for patients moving forward,” said Carrie Hersh, D.O., MSc, staff neurologist at Lou Ruvo Center for Brain Health and site-principal investigator and study steering committee member. “Cleveland Clinic remains dedicated to putting our patients first and the results of the DELIVER-MS trial will be a valuable resource in helping us better understand how to give the best care possible.”
In the three-year study, 800 participants will be enrolled and divided into two sub-groups: randomized clinical trial and observational. Participants in the randomized clinical trial will be categorized to either the early highly-effective treatment approach or the standard escalation approach.
DELIVER-MS is funded by the Patient Centered Outcomes Research Institute as well as the National Multiple Sclerosis Society with research driven by Cleveland Clinic. The Lou Ruvo Center for Brain Health is working in conjunction with Cleveland Clinic in Ohio to conduct the study. Daniel Ontaneda, M.D., clinical director of the brain donation program at Cleveland Clinic’s Mellen Center for Treatment and Research in MS serves as the principal investigator for DELIVER-MS.
“DELIVER-MS will help shape the treatment philosophy of relapsing remitting multiple sclerosis,” said Dr. Ontaneda. “The results will be applicable to a wide range of patients looking to start currently available and future therapies. The long term study results at ten years will further help neurologists and people with MS make informed decisions on initial treatments.”
Men and women ages 18 to 60 who have been diagnosed with relapsing-remitting MS, are early in their disease course, and have not yet started a disease modifying therapy will be eligible to participate. Additionally, interested participants must be able to show evidence of new MRI lesions or have had relapses over the past 12 months, be able to walk independently or with assistance, and be eligible and willing to follow-up at Lou Ruvo Center for Brain Health during the course of the study.
For more information about DELIVER-MS, including how to enroll, contact Nicolette Harmon at (702) 701-7972. For more information about Cleveland Clinic Lou Ruvo Center for Brain Health and other ongoing trials, visit CCF.org/BrainHealthTrials.