More than a hundred participants responded positively to ibudilast, a treatment for multiple sclerosis, in a trial sponsored by the National Institutes of Health (NIH).
Robert J. Fox, a neurologist at Cleveland Clinic, led a team that involved researchers from multiple sites across the United States to investigate the drug. They aim to find out whether the effects of ibudilast was better than placebo in slowing the progression of brain atrophy.
The study was published in The New England Journal of Medicine.
Phase 2 Trial A Success
The study involved 255 patients, all diagnosed with primary or secondary progressive multiple sclerosis, into randomized testing. Volunteers were either asked to take either ibudilast or placebo per day within 96 weeks. Then, every six months, all participants underwent MRI brain scans in order for the researchers to see whether there were differences in the brain shrinkage between those who took placebo versus ibudilast.
Dr. Fox and his team were surprised to see that ibudilast was able to slow down brain shrinkage in patients. Although all patient experienced atrophy, the brains of those who took placebo shrank more rapidly compared to the participants who trialed ibudilast.
"These findings provide a glimmer of hope for people with a form of multiple sclerosis that causes long-term disability but does not have many treatment options," explained Walter J. Koroshetz of National Institute of Neurological Disorders and Stroke.
However, patients who took ibudilast also reported side effects including headache, depression, and gastrointestinal symptoms namely diarrhea and nausea.
"The trial's results are very encouraging and point towards a potential new therapy to help people with progressive MS," added Dr. Fox. "It also increased our understanding of advanced imaging techniques, so that future studies may require a smaller number of patients followed over a shorter period of time. This leads to increased efficiency of clinical research."
The lead researcher also stated that the imaging methods used in the study might also be applicable in observing other neurological disorders in the future.
What's Next
More testing is needed before ibudilast becomes available to patients in the United States. NIH says that additional research is still needed in order to see whether the experimental drug can actually slow down the progression of disability in patients or improve symptoms of people with multiple sclerosis.
Ibudilast has previously been approved as treatment for asthma and dizziness in Japan. It has never been approved in the United States for any other illness.
