Tolerability and Efficacy of CBD Extract for RLS Treatment
Key facts
- Where
- Aurora, United StatesSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 79 years old?
Source: NCT07224932, who can take part
Where in United States
- Colorado Clinical and Translational Sciences Institute (CCTSI) - Anschutz Medical CampusAurora, United StatesContact: Jacquelyn Bainbridge, PharmDNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Colorado, Denver
- Trial code
- NCT07224932
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
A Randomized, Double-blind, Placebo-controlled Parallel Study of the Tolerability and Efficacy of High Cannabidiol (CBD) Cannabis Extract for the Treatment of Patients With Idiopathic Restless Legs Syndrome (RLS)
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.
Inclusion: Male or female subjects between 18 and 79 years of age, inclusive; Willing and able to give informed consent; Idiopathic RLS, meeting all 4 International RLS Study Group diagnostic criteria; Moderate or severe symptoms, defined as an IRLS score ≥ 15 at screening visit; RLS medications unchanged for 4 weeks prior to baseline; Must have a driver or available transportation (including provided Uber vouchers) to drive them to and from study visits and for other transportation needs during the treatment period; Has a significant other, caregiver, or close acquaintance who knows the subject well and agrees to participate in the subject's neuropsychiatric assessment; Agrees to not take more than 1 gram per day of acetaminophen; Whereas applicable, agrees to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment.
Exclusion: Currently on night shift work schedule; Use of dopamine blockers, cocaine, or MAO-A inhibitors within 90 days of baseline; Use of any drugs with known interactions with cannabinoids (e.g., tolcapone, clopidogrel, felbamate, warfarin, barbiturates, benzodiazepines, niacin, nicotinamide, isoniazid, ketoconazole, clobazam, valproate, mTOR inhibitors) within 90 days of baseline; Planned elective surgery during study participation; Secondary RLS, such as Parkinson's disease or end-stage renal disease; Present or past history of another severe sleep disorder; History or diagnosis of schizophrenia, bipolar or a psychotic disorder, severe depression, or any mental health illness that would compromise the safety of the participant; Severe cognitive impairment (e.g., Alzheimer's Disease, traumatic brain injury); Uncontrolled hypertension; Known or suspected allergy or hypersensitivity to cannabinoids or excipients used in the study drug formulation; History of drug or alcohol dependence; Unstable medical condition; Moderate or severe hepatic impairment; Clinically significant laboratory abnormalities; Current suicidal ideation; Pending legal action or workers compensation; Cannabis use (THC) detectable at the screening/baseline visits; Is pregnant, lactating, or has a positive pregnancy test result pre-dose.