At last. a drug to treat ms, migraines, asthma and meth dependence - all my problems solved!

CLEVELAND, Ohio -- People who are diagnosed withmultiple sclerosis at its earliest stages have a variety of treatments available to them that can help stabilize the disease, and a way to track how well that treatment is working.

But for those whose disease has progressed, or who are diagnosed at an advanced stage, physicians have neither the treatments to alter the course of the disease, or monitoring tools to offer.

Researchers at the Cleveland Clinic hope that a new national Phase 2 clinical trial will change that.

The Clinic designed, and will serve as primary investigator of, a trial that will evaluate two things: the safety and effectiveness of a drug called ibudilast, and the effectiveness of magnetic resonance imaging (MRI) as a measurement to see how well the drug is working.

The Clinic’s Mellen Center for Multiple Sclerosis, along with 28 sites across the United States that make up the NeuroNEXT Network, will enroll more than 250 patients (including up to 15 in Cleveland) for the study this fall.

Ohio State University and the University of Cincinnati are the two Ohio-based members of NeuroNEXT, a collaboration of private, public and non-profit institutions established in 2010 by the NIH’s National Institute of Neurological Diseases and Stroke to research treatments for neurological diseases.

The $11.2 million study – the first therapeutic trial for NeuroNEXT - is being paid for by the National Institutes of Health; MediciNova, the Califormia-based pharmaceutical company that is developing ibudilast; and the National Multiple Sclerosis Society.

For years ibudilast has been used in Japan for the treatment of asthma, pulmonary and cardiovascular disease. Elsewhere it has been studied for the treatment of migraines. Earlier this year the Food and Drug Administration granted ibudilast "fast track status" for the treatment of methamphetamine dependence.

Dr. Robert FoxCleveland Clinic 

Lab studies have shown some evidence that the drug is effective in protecting the brain from inflammation, said Dr. Robert Fox, principal investigator of the trial and staff neurologist at the Clinic’s Mellen Center.

“We’ve put together a skill set in our clinical MS, radiology, biomedical engineering and ophthalmology groups,” Fox said of the Clinic being selected to lead the trial.

“Even if therapy doesn’t work – and I hope that it does - we will learn how to do progressive MS trials and which biomarkers [work], so future trials will know what metrics to use,” he said.

Patients chosen for the study will be in one of two groups – those who take the pill twice a day, and those who take a placebo (inactive) pill. Patients will take the drugs for 96 weeks and will be evaluated with MRI every six months.

One of Fox’s patients, Donna Kolb of Pepper Pike, says she hopes she qualifies for the study.

Diagnosed with multiple sclerosis in 1994, Kolb, 53, said that other than numb fingers, she initially wasn't bothered by symptoms.

Within five years of her diagnosis, Kolb had married her husband, Greg, and had given birth to two sons. Once she weaned her youngest son from breastfeeding, Kolb started taking the injectable drug Avonex weekly for her relapsing MS. After 11 years, she switched to a pill called Copaxone.

“Nobody even knew I had MS,” Kolb said. But then she started having more pronounced difficulty walking. The stress of her parents’ deaths within weeks of each other in 2009 seemed to worsen her symptoms, she said.

For the past three years, Kolb has been taking the drug BG-12 as part of a five-year clinical trial for treating relapsing-remitting MS.

But Kolb, who now has progressive MS, said she would gladly withdraw from that study if given the chance to participate in the ibudilast trial.

“Things are getting harder each day,” she said of her symptoms, which now include blurred vision. “I was a very active person. [But now] everything takes a little longer. A shower. Getting dressed.”

While drugs can help manage Kolb’s symptoms, researchers continue developing therapies that will stabilize or slow down progressive MS.

Lab studies have shown that cannabis (marijuana) has some neuroprotection characteristics. But a study published online July 13 in the journal Lancet Neurology showed that it was not effective in treating progressive MS.

“There are patients who say that it helps with specificity and pain,” Fox said. But the big challenge is that the potential medicinal benefit can’t be derived without the psychotropic effects, or the “high”, that also comes with it.

Several other MS clinical trials, including a study using adult stem cells that is winding down after two years, are at the Clinic. Others will begin this fall.