Not Yet RecruitingPhase 2

Tolerability and Efficacy of CBD Extract for RLS Treatment

60 participantsStarted 2025-12-19

Plain-language summary

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 can participate

Age range18 Years – 79 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Secondary RLS, such as Parkinson's disease or end-stage renal disease.
✕. Present or past history of another severe sleep disorder.
✕. Currently on night shift work schedule.
✕. 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.
✕. Current suicidal ideation.
✕. 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.

What they're measuring

To examine the safety and tolerability of oral high CBD extract in idiopathic RLS assessed by frequency of adverse events which will be monitored by patient reported adverse events, vital signs, physical exam, and safety labs during study visits.

Timeframe: Baseline, Visit 3, Visit 4, Visit 5

Trial details

NCT IDNCT07224932

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-01

Contact for this trial

Jacquelyn Bainbridge

303-810-4254 Jacci.Bainbridge@cuanschutz.edu

View on ClinicalTrials.gov More Restless Leg Syndrome trials