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University becomes part of national network for brain health

The University Health System gears up to look for solutions to MS

The University Health System has joined a national effort to seek treatments for neurological diseases, taking part in the SPRINT-MS trial within the Network for Excellence in Neuroscience Clinical Trials, also known as NeuroNEXT. The network, made up of 28 hospitals, is sponsored by the National Institute of Neurological Disorders and Stroke, which is part of the National Institutes of Health.

“[The trial] is being conducted within the NeuroNEXT network, which is a standing entity to do multiple early phase and biomarker trials in adults and children with all kinds of neurological diseases,” said Dr. E. Clarke Haley, principal investigator for NeuroNEXT at the University.

The two-year SPRINT-MS trial tests the effectiveness of a new medication, Ibudilast, in adults aged 21 to 65, with progressive multiple sclerosis, an autoimmune disorder that affects more than 400,000 Americans, according to data from the National Multiple Sclerosis Society.

“There is a critical need for proven therapy for [the] progressive disease MS,” said Dr. Myla Goldman, director of the University’s James Q. Miller Multiple Sclerosis Clinic. “This study addresses this issue, but tests a safe and accessible agent with early-phase research to support a benefit in this population.”

Currently, there are no approved treatments for patients with progressive MS. Doctors hope to use the NeuroNEXT collaboration to stay updated with the latest research and technology.

“MRIs will be used with advanced imaging techniques called magnetization transfer, diffusion tensor and special calculations of brain atrophy,” Goldman said. “These tools give us a more detailed picture of what is happening in the brain than what can be seen on a routine MRI.”

Goldman said she does not anticipate major difficulties in conducting the SPRINT-MS trial.

“Recruitment is always a challenge in clinical research,” Goldman said. “However, due to the profound need in the progressive MS patients, we have had a lot of interest. We will need to continue our recruitment efforts to ensure we have the numbers of subjects needed to determine the benefit of this drug.”

Volunteers in the trial will receive either Ibudilast or a placebo twice a week for 96 weeks. The trial will measure the effectiveness of the medication through brain imaging to examine brain tissue loss in patients.

“One of the important things about the network is that it [considers] drugs that have the potential for benefit but may have been neglected by a pharmaceutical company and brings them into the research marketplace where we can then determine whether or not there is benefit,” Goldman said.

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