Tolerability and Efficacy of CBD Extract for RLS Treatment

NCT07224932 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 23-0682
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Restless Leg Syndrome

Keywords

Restless Leg Syndrome; cannabis; BRC-002

Outcome Measures

Primary Outcomes (1)

• 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.

  Participant reports measures the frequency of adverse events. This will be done with open-ended questions during patient visits and phone calls. Abnormal vital signs (BP, HR, RR) at patient visits measures the frequency of participants with adverse events. BP over 130/80 mmHg indicates worse outcomes. Lower scores indicate worse outcomes. HR ranges from 60 to 100 bpm; Scores outside this range indicates worse outcomes. RR ranges from 12-20 bpm. Scores outside this range indicated worse outcomes. A neurological exam and routine physical exam will be preformed to examine adverse events. Abnormal findings will constitute as an adverse event. Labs (serum CBC w/ diff, serum CMP, urinalysis) will measure frequency of adverse events. Abnormal CBC w/diff, CMP, and urinalysis values will be determined by lab ranges.

  Baseline, Visit 3, Visit 4, Visit 5

Secondary Outcomes (13)

• To examine the effect of BRC-002 on RLS symptoms assessed through changes from baseline in RLS-6 Severity Scale

  Baseline; Day 20

• To examine the effect of BRC-002 on RLS symptoms assessed through changes from baseline in change from baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS)

  Baseline; Day 20

• To examine the effect of BRC-002 on RLS symptoms assessed through changes in sleep quality index (SQI) as measured by the SleepImage Ring

  Baseline; Day 20

• To examine the effect of BRC-002 on RLS symptoms assessed through changes in the Pittsburgh Sleep Quality Index (PSQI).

  Baseline; Day 20

• To examine the effect of BRC-002 in sleep measured by change in the Epworth Sleepiness Scale (ESS)

  Baseline; Day 20

Study Arms (2)

Placebo Comparator

PLACEBO COMPARATOR

Half of the patients will be randomized to receive placebo orally. It is an oral solution of mono-, di-, and triglycerides

Drug: Placecbo

BRC-002

EXPERIMENTAL

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.

Drug: BRC-002

Interventions

BRC-002 DRUG

BRC-002 is a non-scheduled cannabidiol (CBD) formulation (\<0.3% THC). The cannabinoids in BRC-002 are naturally biosynthesized within the Cannabis sativa L. plant. BRC-002 is a high Cannabidiol Botanical extract (100 mg/mL).

Also known as: Cannabidiol Formulation

BRC-002

Placecbo DRUG

Oral solution of mono-, di-, and triglycerides

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pending legal action or workers compensation.
• Cannabis use (THC) detectable at the screening/baseline visits.
• History of drug or alcohol dependence.
• 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.
• Unstable medical condition.
• Clinically significant laboratory abnormalities.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• BRC Therapeutics: collaborator
• Biopharmaceutical Research Company: collaborator

MeSH Terms

Conditions

Restless Legs Syndrome; Marijuana Abuse

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Jacquelyn Bainbridge

  Skaggs School of Pharmacy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacquelyn Bainbridge

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: November 5, 2025
• Study Start: December 19, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 25, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share