Stefan Clemens, PhD, an associate professor at East Carolina University’s (ECU) Brody School of Medicine’s Department of Physiology, was awarded United States Patent 10,751,327 on Aug 25 for his invention providing methods of treating restless legs syndrome (RLS) including administering a dopamine D1 receptor antagonist.

While the exact cause of RLS is still unknown, the syndrome is typically treated with dopaminergic drugs—medications that replace or prevent the loss of dopamine—that have a high initial effect but over time lose their effectiveness.

“The problem is that patients on these dopaminergics eventually develop a side effect called augmentation,” Clemens says in a release. “Their symptoms get worse while taking the current medication used for treatment.”

Classic RLS treatments act on a dopamine receptor known as D3 that has a suppressive effect in the nervous system. But Clemens’ lab has shown in animal models that over time this medication leads to an increase of a different, excitatory receptor subtype, D1. This increase of the D1 receptor might be the cause of augmentation.

[RELATED: Preventing and Managing Augmentation in Restless Legs Syndrome]

Clemens’ patent proposes a new treatment method that targets the increased D1 receptor levels in RLS patients experiencing augmentation, leading to reduced activation of D1 receptors while providing traditional therapy relief from RLS.

“Our lab postulates that this new compound will maintain long-term efficacy for RLS,” Clemens says “If augmentation begins, we predict that we can reduce D1 receptor activation in patients and balance things back out, keeping the treatment effective.”

Clemens was awarded a grant from the North Carolina Biotechnology Center to run a small pilot study with a collaborator from the University of Houston using this new treatment method.

This work has gained the attention of a company that has interest in establishing a partnership where ECU’s patent rights may be used in combination with its existing drug formulation to bring relief to RLS patients experiencing augmentation.

The idea to apply for a patent came from ECU’s Office of Licensing and Commercialization. “They not only brought the idea of patenting our research to my attention, but they also helped me through the process and handled all of the legal and technical aspects of filing a patent,” Clemens says. “The patent would not have been issued without their help. I now know that it can be very beneficial to have experts in other areas come from different angles that make us think of other ways to use our work.”

Marti Van Scott, director of licensing and commercialization, says that finding commercialization opportunities for faculty research is an important bridge that brings science into the communities the university serves.

[RELATED: Are Dopamine Agonists Doing More Harm Than Good for Restless Legs Syndrome Patients?]

“It is a pleasure to work alongside our faculty to identify translational research opportunities that have potential to make a meaningful impact,” Van Scott says in a release. “Licensing and commercialization works hard to identify skilled development partners to offer essential guidance for these translational activities. Whether it’s a new therapeutic or medical device, teaching or training method, or research tool, we are available to support the campus research and innovation ecosystem.”

While Clemens’ lab continues to work on its RLS treatment, Clemens also continues to work on other medical treatments, including care for opioid pain tolerance.

Photo: Clemens, along with associate professor Kori Brewer, PhD, examine a mouse’s spinal column in their lab at the Brody School of Medicine. Clemens’ work with mouse models was essential in helping him develop his Restless Legs Syndrome treatment. Credit: Cliff Hollis/East Carolina University