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Cleveland Clinic has been selected as the primary investigator in a $11.3 million nationwide study funded primarily by the National Institutes of Health to conduct a trial of the oral drug ibudilast for progressive multiple sclerosis (MS) patients.
The Phase 2 study will enroll patients at 28 clinical sites across the U.S. The trial is designed to evaluate the safety, tolerability and efficacy of ibudilast, which will be given twice daily to patients with progressive MS. This is a placebo-controlled trial with the goal of recruiting over 250 patients.
“Currently, progressive MS patients do not have any treatments that will alter their long-term disease course, and it is essential we conduct trials to try to identify an effective treatment,” said Robert Fox, M.D., M.S., FAAN, Principal Investigator of the trial and Staff Neurologist at the Mellen Center for Multiple Sclerosis at Cleveland Clinic. “This trial will not only study a potential treatment for progressive MS, but will further the knowledge of the best methodologies for evaluating therapies. This will lead to researchers being able to create shorter, more effective trials and getting therapies to patients faster.”
The primary goal of the study is to evaluate the activity of ibudilast versus placebo at 96 weeks as measured by magnetic resonance imaging (MRI) analysis for whole brain atrophy using brain parenchymal fraction (BPF). The secondary goal is to evaluate the safety and tolerability of ibudilast (100 mg/day) versus placebo administered orally in subjects with progressive multiple sclerosis. A variety of secondary outcomes will evaluate additional advanced imaging measures and will utilize imaging and biomedical engineering expertise at Cleveland Clinic.
The clinical trial will be conducted by the NeuroNEXT Network, representing that group’s largest collaborative effort to date.
The NeuroNEXT Network was created to conduct studies of treatments for neurological diseases through large partnerships and collaborations, leveraging the strengths of multiple organizations in the private, public, and non-profit sectors. The network is designed to expand the capability of The National Institute of Neurological Disorders and Stroke (NINDS) to test promising new therapies, increase the efficiency of clinical trials before embarking on larger studies, and respond quickly as new opportunities arise to test promising treatments for people with neurological disorders.
The clinical coordinating center for this trial is Massachusetts General Hospital, and the data coordinating center is the University of Iowa. Dr. Fox and his colleagues at Cleveland Clinic will collaborate with co-investigators at 28 additional academic medical centers in the NeuroNEXT network. The National Multiple Sclerosis Society provides patient advocate input and trial enrollment awareness and has provided additional funding to increase patient access to the trial and increase patient safety.
The trial is expected to require approximately three years for enrollment, treatment, and data analyses. The drug is already approved in Japan for asthma.