Since the University of Michigan created its Multiple Sclerosis Center in 2007, Michigan has been fighting a good fight against MS. Under the direction of Benjamin Segal, M.D., the center has grown from 400 patients and one physician to 3,000 patients and six specialty physicians. This growth represents an all-out war against MS, with clinical, translational and clinical research arms. The strategy is working so well that the center was designated a Center of Excellence for Comprehensive MS Care by the National Multiple Sclerosis Society (NMSS).
The center takes a multidisciplinary approach, collaborating with physical medicine, pain specialists, urologists and neurologists. “All in the interest of helping our patients in the most expert way,” says Segal.
In addition to providing patient care in the outpatient clinic, the center is conducting several clinical trials for both relapsing remitting and secondary progressive MS to further the treatment options for the disease.
Siponimod Phase III – Largest Trial in the World
Dr. Yang Mao-Draayer is principal investigator and Segal is co-investigator on a Phase III trial to see how the drug siponimod impacts the immune system in patients with secondary progressive MS. Siponimod is a variation of fingolimod, a drug that is used in relapsed or remitting MS patients but was designed to have fewer side effects.
The study involves more than 300 centers around the world, is the largest secondary progressive MS trial ever conducted and includes nearly 1,600 subjects worldwide. “Our study is the first in-depth immunological study of its kind for MS and involves a unique collaboration among 19 US academic centers, Novartis and the National Institutes of Health,” says Yang.
Surprising Connections Between Sleep Disorders and MS
Dr. Tiffany J. Braley is interested in the causes of fatigue in MS and how to better treat it.
“It turns out that a good portion of people with MS have a sleep disorder that is contributing to their fatigue,” says Braley.
Obstructive sleep apnea (OSA) is underdiagnosed in MS patients, and Braley has found that such sleep disorders are more common in patients with MS than the general population. She is studying whether the effects of the disease itself as well as the treatments given to patients to decrease relapse rates impact patients’ sleep hygiene and put them at a higher risk for OSA.
She has started an MS/sleep and fatigue subspecialty clinic—the first of its kind in the country—where she and Dr. Ronald Chervin, director of the U-M Sleep Medicine Division, evaluate and treat MS patients with severe fatigue, tiredness and sleep disorders.
“In addition, I am looking at whether or not some medications that are used to treat MS may help alleviate sleep apnea in the general population,” Braley says. “We continue to find connections between the two conditions.”
Extracorporeal Photophereresis – Enrolling for Trial Now
“I am one of the people who believes inflammation plays a role during all stages of MS. However, every patient is unique,” says Segal. “The type of inflammation that causes damage may vary between individuals. This may be why there is no immunoregulatory drug that is effective across all patient subsets.”
There are now 13 FDA-approved medications that decrease risk of clinical exacerbation in patients in the relapsing-remitting stage of MS. “However, we do not have a cure, and there are no highly effective medications that slow, let alone reverse, the accumulation of disability in patients in the progressive stages of MS,” he says.
So Segal has tried a different approach, concentrating on the idea of combating inflammation in progressive MS, but coming at it from a different direction. “One of my colleagues, Dr. Daniel Couriel, chief of the Bone Marrow Transplant unit, uses a technique called extracorporeal photopheresis (ECP) to treat graft versus host disease—an inflammatory disease of multiple organs that occurs in some patients following bone marrow transplantation. In a way, it’s like an autoimmune disease,” he says.
ECP is a relatively safe procedure involving removal of some white blood cells from a patient, exposing those cells to UV light in the presence of a photosensitizing agent and then reinfusing those cells.
Segal and Couriel used ECP on a father of two with progressive MS who had not responded well to other treatments, even chemotherapy.
“He went from spending most of the day in a motorized scooter to walking with a cane. A second patient could stand in the shower for the first time in years. A third did not make gains but she did not deteriorate either.”
“As far as I know, we’re the only site in the world that’s doing this procedure in this way to treat progressive MS,” Segal says.
“Compared to other MS treatments, it is relatively low risk. And if this works, it will be a huge advancement in the management of progressive MS,” Segal says.
FOR REFERRING PHYSICIANS
ECP – Enrolling for Trial Now
Patients with secondary progressive MS not currently treated with disease modifying therapies may be eligible for the ECP trial. Trial candidates should have experienced disability accumulation over the past 1-2 years. Please contact Amanda Rasnake, clinical trial coordinator, at (734) 232-2452 if you would like to refer a patient to the trial.
This clinical trial will evaluate the effects of Positive Airway Pressure (PAP) on cognitive function in multiple sclerosis patients who have obstructive sleep apnea. MS patients who have concerns about their cognitive function or who are at risk for obstructive sleep apnea may be eligible.
Please contact study coordinator Nancy Kessler (734) 647-9067, firstname.lastname@example.org, if you would like to refer a patient to this trial.