CBD Extract for Restless Legs Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This study plans to learn more about the safety and tolerability of high Cannabidiol (CBD) cannabis extract (BRC-002) for use in Idiopathic Restless Legs Syndrome. Symptoms and side effects experienced while taking the study drug will be tracked to determine if this medication is safe to use.
Who Is on the Research Team?
Jacquelyn Bainbridge
Principal Investigator
Skaggs School of Pharmacy
Are You a Good Fit for This Trial?
This trial is for adults aged 18-79 with moderate to severe idiopathic Restless Legs Syndrome (RLS) whose symptoms and medications have been stable. Participants need reliable transportation, a close contact for assessments, and must agree to use contraception if applicable.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- BRC-002
Trial Overview
The study compares a high-CBD cannabis extract (BRC-002) against a placebo in people with RLS. It aims to see how safe and tolerable the CBD extract is by tracking symptoms and side effects during treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Half of patients will be randomized to receive oral investigational product. BRC-002 is a non-scheduled high cannabidiol cannabis extract (\<0.3% THC). The cannabinoids in BRC-002 are naturally biosynthesized within the Cannabis sativa L. plant.
Half of the patients will be randomized to receive placebo orally. It is an oral solution of mono-, di-, and triglycerides
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Biopharmaceutical Research Company
Collaborator
BRC Therapeutics
Collaborator
Biopharmaceutical Research Company
Industry Sponsor
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