University of Colorado Anschutz Skaggs School of Pharmacy and Pharmaceutical Sciences Professor Jacci Bainbridge, PharmD, has launched a Phase 2 clinical trial as principal investigator to evaluate a proprietary cannabidiol (CBD) formulation as a potential treatment for idiopathic Restless Legs Syndrome (RLS). Funded by BRC Therapeutics, the study begins enrolling adult participants this July, marking an important milestone in the search for new evidence-based therapies for a neurological disorder that has limited treatment options.
Millions Live with RLS. Effective Treatments Remain Limited.
RLS causes an overwhelming urge to move the legs and/or limbs, most often during periods of rest in the evening or at night. People living with RLS frequently describe uncomfortable sensations such as aching, throbbing, pulling, itching, crawling, or creeping deep within their legs. The symptoms make relaxation and sleep nearly impossible.
“It’s not just that your legs want to move,” she said. “It can be many things to many people, and the thing that relieves that sensation is getting up and moving.”
Diagnosing RLS can be particularly challenging because there is no single test that confirms the condition. Instead, providers must rely on a patient's symptoms and medical history while ruling out other possible causes, making RLS a diagnosis that often comes only after a lengthy process of elimination.
Treatment is equally frustrating. Because the exact cause of RLS is unknown, there is no cure, and treatment involves addressing underlying conditions that may worsen RLS, such as iron deficiency, diabetes, neuropathy, or sleep apnea; lifestyle changes; and in severe cases, opioids, benzodiazepines, and other neurological medications. As Bainbridge puts it, nothing is the magic bullet, and sometimes treatment can make the symptoms worse.
Putting CBD to the Test
That unmet need is what makes this clinical trial significant. A Phase 2 clinical trial is the initial step in testing an experimental drug or treatment in humans, and its primary goal is to evaluate safety, identify side effects, and determine the safest dosage.
A growing body of research suggests CBD may have therapeutic potential for neurological conditions, but its effectiveness for RLS remains largely unexplored. Bainbridge aims to help answer that question.
CBD is a non-intoxicating compound derived from the cannabis plant that interacts with the body's endocannabinoid system, which plays a role in regulating sleep, pain perception, mood, and other physiological functions. In late 2025, Bainbridge received funding from BRC Therapeutics to evaluate the company's proprietary CBD formulation in patients with RLS.
BRC develops prescription cannabinoid-based therapies for chronic pain, neurological disorders, and inflammatory diseases. Recognizing Bainbridge's longstanding expertise in neurology clinical trials, and her previous success with CBD, the company partnered with her to conduct the study, which seeks to generate critical evidence on the safety and potential effectiveness of its investigational therapy for patients with RLS.
“If this can be another solution, we really want to find that solution,” she stressed.
Advancing the Science
Every clinical trial has the potential to reshape the future of patient care. Throughout the study, Bainbridge and the research team will closely monitor participants and collect the rigorous clinical data needed to determine whether this proprietary CBD formulation is a safe and effective treatment for RLS.
The findings could help fill a critical gap in the evidence surrounding cannabinoid-based therapies for neurological disorders and lay the foundation for larger clinical studies. For Bainbridge, the trial represents an important step toward expanding treatment options for a condition that has long lacked effective therapies.
Years of scientific investigation and months of regulatory preparation have led to this moment. Enrollment begins this July at the CU Anschutz medical campus. Adults interested in participating can learn more about the study and review eligibility requirements at ClinicalTrials.gov (Study ID: NCT07224932) or contact study coordinator Hannah Karam at Hannah.Karam@cuanschutz.edu.
Video created by Alicia Facer, CU Anschutz Pharmacy.
