Study finds drug slows brain shrinkage in people with MS

brain scan image
The anti-inflammatory drug ibudilast may slow brain shrinkage caused by progressive MS. Robert J. Fox, M.D., Cleveland Clinic, OH.

A recent study published in the New England Journal of Medicine found that the drug ibudilast slows down brain shrinkage in people with multiple sclerosis (MS).

Clinical trial results showed that ibudilast slowed the rate of brain atrophy by 48 percent among 255 participants with progressive MS when compared with an inactive placebo.

The Clinical Trials and Statistical Data Management Center (CTSDMC) based at the University of Iowa College of Public Health served as the data coordinating center for this study. The center is part of the NeuroNEXT group, a nation-wide network founded in 2011 to conduct efficient and rigorous phase II and biomarker studies across all areas of the neurosciences.

Christopher Coffey, professor of biostatistics at the University of Iowa, director of the CTSDMC, and co-author of the study, says that this study is the first phase II intervention study completed by the NeuroNEXT.

Chris Coffey
Chris Coffey

“These findings are in alignment with the overall objective of the Network for conducting rigorous phase II studies with clear go/no-go criteria for determining whether further study in larger, confirmatory studies is warranted,” says Coffey. “This is a major milestone for NeuroNEXT, since it is a high bar to get a phase II clinical trial published in a journal as prestigious as the NEJM.”

Coffey says that while the results of the study are encouraging and exciting, larger studies are needed to determine whether similar benefits are observed with respect to clinical endpoints of interest.

According to the researchers, future studies will test whether reducing brain shrinkage affects thinking, walking, and other problems in people with MS and will examine whether ibudilast slows the progression of disability in MS patients.

This study was supported by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.

Additional Media Coverage

Study finds multiple sclerosis drug slows brain shrinkage (NIH)
https://www.nih.gov/news-events/news-releases/study-finds-multiple-sclerosis-drug-slows-brain-shrinkage

New Drug Shows Promise For Patients With Progressive Multiple Sclerosis (CBS Chicago)
https://www.youtube.com/watch?v=wugg1eDvdpU

Drug may slow down brain shrinkage in multiple sclerosis, study says (UPI)
https://www.upi.com/Health_News/2018/08/30/Drug-may-slow-down-brain-shrinkage-in-multiple-sclerosis-study-says/4201535633096/

 

Coffey to present CPH Distinguished Faculty Lecture Aug. 29

UI College of Public Health 2018 Distinguished Faculty Lecture

Chris CoffeyWe Built This Network: How NeuroNEXT Increases Innovative Design in Academic Trials

 

Chris Coffey, PhD
Professor of Biostatistics and Director of the Clinical Trials Statistical and Data Management Center
College of Public Health, The University of Iowa

Wednesday, August 29
12:30 p.m.
Callaghan Auditorium
N110 College of Public Health Building

A reception will follow in the CPHB atrium.


The traditional approach to clinical trials tends to be large, costly, and time-consuming. Correspondingly, there is a need for more efficient clinical trial design, which has recently led to substantial interest in the use of innovative trial designs.

For example, adaptive designs allow reviewing accumulating information during an ongoing clinical trial to possibly modify trial characteristics. Although there are a large number of proposed adaptations, regulatory groups support the notion that all changes should be based on pre-specified decision rules. This often requires research groups to conduct properly designed simulation studies in order to confirm that the proposed adaptations preserve the integrity and validity of the study.

To address this issue, there has been an industry movement towards creating in-house teams primarily responsible for planning and conducting such simulations. Greater barriers exist for implementing this same type of infrastructure within the academic clinical trials environment. For example, the simulations would need to be conducted before the design is finalized – which must occur well before a typical grant submission to support funding for a proposed trial. For researchers who are completely grant-funded, few mechanisms exist to support these complex simulation studies.

As a result, there is a growing divide between the practicality and feasibility of conducting adaptive designs in industry compared to academia. Since acceptance of adaptive designs in general will depend on increasing their use across all types of clinical trials, infrastructure-building efforts are needed within the academic clinical trials environment in order to help further advance the use of adaptive designs.

One recent example of such an effort is the creation of the NINDS-funded Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT). The Network infrastructure provides support for a group of senior statisticians with a great deal of experience in protocol and grant development for clinical trials. This infrastructure dramatically increases the feasibility for using more novel trial designs – including adaptive designs.

In this presentation, Dr. Coffey will provide a summary of the NeuroNEXT experience to date and illustrate how initiatives like NeuroNEXT greatly increase the practicality of using adaptive designs in an academic trials setting.

 

Individuals with disabilities are encouraged to attend all University of Iowa–sponsored events. If you are a person with a disability who requires a reasonable accommodation in order to participate in this program, please contact the College of Public Health in advance at 319-384-1500.

Video: CTSDMC helps research move forward

Clinical trials for neurological diseases are long and arduous. See how the Clinical Trials and Statistical Data Management Center at the University of Iowa is helping to simplify the process by coordinating data for NeuroNEXT network.

Biostat’s CHAMP study cited as one of “Best Advances of 2016”

The College of Public Health’s Clinical Trials Statistical and Data Management Center (CTSDMC) contributed to a 2016 children’s migraine study that was recently selected by editors at the American Academy of Neurology as one of the most important advances of the year.

The CHAMP study, co-authored by biostatistics professor and CTSDMC director Christopher Coffey, found that prescribed medications are no more effective than a placebo when used to prevent migraines in children and teens. The study was published in the New England Journal of Medicine.

Bruce Cohen, professor of pediatrics at Northeast Ohio Medical University and a member of the academy’s editorial advisory board for the weekly publication, Neurology Today, identified the CHAMP study as one of only two studies that met the criteria for “Best Advances of 2016” in the Pediatric Neurology category. The designation is intended to highlight “the most important advances, policies, and professional issues that occurred during the past 12 months,” according to the publication.

Joe Cavanaugh, professor and head of the Department of Biostatistics, said the citation was “impressive recognition of a study that will clearly have a profound impact on the treatment of pediatric migraines.”

“Yet another example of the stellar research being conducted by our colleagues in the CTSDMC!” said Cavanaugh.