UI plays key role in groundbreaking multiple sclerosis research study

The UI served as the data-coordinating center for a phase II study on the drug Ibudilast, which showed the drug slows brain atrophy in people suffering from multiple sclerosis by nearly 50 percent over a two-year period.


Megan Nagorzanski

Professor Christopher Coffey worked as part of the research team that discovered a drug that slows brain shrinkage in people with multiple sclerosis. Coffey spoke about his research on Sept. 5, 2018.

Josie Fischels, News Reporter

The University of Iowa’s Clinical Trials and Statistical Data Management Center served as a data-coordinating center for a recent study that found the drug Ibudilast slows brain atrophy, or shrinkage, in people suffering from multiple sclerosis by 48 percent.

The study, proposed and led by neurologist Robert J. Fox of Cleveland Clinic in Ohio, sought out the UI as a data-coordinating center. The study involved 255 MS patients at 28 centers around the country and has only recently had results published after six years of research.

“All of that data needed to be funneled together into a single data set at the University of Iowa,” Fox said.

UI biostatistics Professor Chris Coffey, the director of the data center, is the principal investigator of NeuroNEXT, a national network founded in 2011 to efficiently conduct Phase 2 studies of treatments for neurological diseases. The UI’s role as the data center in NeuroNEXT made it the ideal place to collect and analyze data for the MS study.

The network also involves 28 other sites and the Clinical Coordinating Center in Boston, all working together to streamline Phase 2 research. 

“The idea of putting the [NeuroNEXT] together was that you had this kind of existing infrastructure in place, and then, as new proposals came in for Phase 2 trials that needed that help, they could tap into the network, and all that expertise was there so someone wouldn’t have to pull it together from them from scratch,” Coffey said.

Coffey and NeuroNEXT have been hard at work supporting studies such as this since the network’s founding, helping to conduct trials to find treatments for such diseases as Huntington’s, myasthenia gravis, fragile X syndrome, and glioblastoma multiforme, according to an Iowa Now article.

Marianne Chase, the director of research operations at the Clinical Coordinating Center of NeuroNEXT, said the UI and Massachusetts General Hospital worked very closely together during the study, allowing the course of the study to run smoothly and efficiently.

“We joke and say [NeuroNEXT] is like an ‘arranged marriage’ between the Clinical Coordinating Center and the Data-Coordinating Center, with 28 children, all arranged by the National Institutes of Health,” she said.

We spent five, six years working on the study, so it’s nice to see something good come at the end of all the hard work.

Because many of the trials for treatment take several years to complete and require three phases of research and studies, Coffey said, publishing results is often a slow process. This phase of the study showed that the drug slowed brain atrophy by 48 percent over a two-year period, meaning every patient involved in the study required a two-year follow-up.

“It was really nice to see it come to fruition and then to actually have impact has been a positive thing,” Coffey said. “We spent five, six years working on the study, so it’s nice to see something good come at the end of all the hard work.”

While the study must now move into Phase 3 before ibutalast can officially be confirmed and approved by the FDA as a beneficial, safe drug to be prescribed to people with MS, the study is a major milestone for NeuroNEXT, according to the UI College of Public Health website. The results were recently published in the prestigious New England Journal of Medicine.

“This study in particular went really well,” Chase said. “Everyone worked really well together, and operationally, we were very happy with it. The results were positive, which was fantastic for both NeuroNEXT and multiple-sclerosis research. We’re all very excited about where the study will go next.”