New drug could treat muscle spasticity in MS by boosting the body’s own processes

The University of Cincinnati’s Shahla Hosseini, MD, PhD, said while there is currently no true cure for spasticity, it is typically managed with various treatments based on each person’s needs, including oral medications and injections.

Now the University of Cincinnati Gardner Neuroscience Institute is a trial site for a new clinical trial testing an oral drug that enhances naturally occurring molecules in the body to help muscles relax as a treatment for spasticity in patients with MS.

“Physicians who treat muscle spasticity have a limited number of medications from which to choose. In the past 20 to 30 years, we haven’t seen development of new effective oral medications to treat spasticity in the United States,” said Hosseini, adjunct associate professor of Physical Medicine and Rehabilitation in the Department of Neurology and Rehabilitation Medicine in UC’s College of Medicine and a UC Health physician. “The majority of the currently available oral medications have side effects like drowsiness, which limits their usefulness during the daytime, and so we really need a new effective treatment for spasticity that’s better tolerated by patients.”

The body naturally produces molecules called endocannabinoids that help muscles relax and play a role in other functions, including regulating mood, pain and sleep, Hosseini explained. The trial drug is designed to inhibit two enzymes that break down endocannabinoids, monoacylglycerol lipase (MAGL) and fatty acid amide hydrolase (FAAH), allowing the endocannabinoids to help regulate the overly reactive spastic muscles.

“It’s enhancing the natural molecules that are made by the body,” Hosseini said. “Some endocannabinoid levels have been found to be lower in people with MS. This finding makes the drug’s mechanism even potentially more relevant to this group if it is able to help normalize their levels of endocannabinoids.”

In this international, multicenter Phase 2 trial, approximately 200 people with MS across multiple sites will be randomized to take one of three doses of the trial drug or a placebo daily for six weeks. An optional additional six weeks will compare effects of only the three different doses on treating spasticity, meaning participants who began on the placebo will be guaranteed to receive the trial drug during this period.

Hosseini noted that spasticity also affects people with other neurological diseases involving the brain and spinal cord. If the trial drug is found to be effective in this study of MS participants, it may show promise for wider use as another tool for clinicians in addition to current treatments such as stretching, yoga, botulinum toxin injections and physical and occupational therapy.