CU Anschutz Launches Phase 2 Trial of CBD Formulation for Restless Legs Syndrome
Key Insights
Professor Jacci Bainbridge at CU Anschutz is leading a Phase 2 clinical trial evaluating a proprietary CBD formulation for idiopathic Restless Legs Syndrome (search), with enrollment beginning in July.
The study, funded by BRC Therapeutics (search), addresses a neurological disorder affecting millions that currently has limited evidence-based treatment options.
A separate Spanish open-label study found that a THC/CBD combination significantly reduced RLS severity, with 67% of patients showing sustained improvement after one year.
A new Phase 2 clinical trial led by Professor Jacci Bainbridge, PharmD, at the University of Colorado Anschutz (search) Skaggs School of Pharmacy and Pharmaceutical Sciences is set to investigate a proprietary cannabidiol (CBD) formulation as a potential treatment for idiopathic Restless Legs Syndrome (search) (RLS). Funded by BRC Therapeutics (search), the study begins enrolling adult participants this July, marking a significant step in the search for evidence-based therapies for a neurological disorder that affects millions yet has limited treatment options.
"It's not just that your legs want to move," Bainbridge said. "It can be many things to many people, and the thing that relieves that sensation is getting up and moving."
The Diagnostic Challenge of RLS
Diagnosing RLS remains particularly challenging because no single test can confirm the condition. 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. This diagnostic complexity, combined with the limited therapeutic arsenal, underscores the unmet medical need that the CU Anschutz trial seeks to address.
Shifting Treatment Paradigms
The treatment landscape for RLS has been evolving. Researchers have noted that while dopamine agonists have traditionally served as the first-line treatment, recent studies signal that gabapentinoids (search) are now being recommended. Cannabinoids, like gabapentinoids, inhibit a certain type of amino acid associated with the disorder, providing a scientific rationale for investigating their therapeutic potential in RLS.
Supporting Evidence from Spain
The CU Anschutz trial builds on emerging research into cannabinoid-based therapies for RLS. An exploratory open-label study conducted by researchers at Universidad Europea de Madrid and published in the Journal of Neurology evaluated a cannabis product containing 2.7mg THC and 2.5mg CBD in 18 patients with RLS, including those with multiple sclerosis and associated idiopathic RLS. The study found that the formulation "was effective in reducing RLS severity."
"Improvements were observed after 1 and 3 months of treatment and were maintained after 1 year among patients who continued therapy," the researchers reported. Among those who remained on treatment after one year, 67 percent "continued to show sustained improvement."
The Spanish findings are notable given that cannabis is well-known to reduce the severity of muscular spasms and related conditions, though its specific efficacy for RLS has been less studied. RLS may also present as a symptom of overarching disorders such as multiple sclerosis, further broadening the potential relevance of cannabinoid-based interventions.
A New Chapter in RLS Research
The CU Anschutz Phase 2 trial represents a focused effort to generate rigorous clinical evidence for a CBD-specific formulation in idiopathic RLS, distinct from the THC-containing products studied elsewhere. With enrollment opening in July, the trial aims to provide clarity on whether a proprietary CBD formulation can offer meaningful relief to the millions living with this often-debilitating condition.