Tolerability and Efficacy of CBD Extract for RLS Treatment

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Restless Leg Syndrome
• Intervention / Treatment: Drug: Placecbo; Drug: BRC-002

Detailed Description

This randomized, placebo-controlled clinical trial will evaluate the safety, tolerability, and therapeutic effects of a high-CBD botanical extract in patients with idiopathic RLS. The study will examine changes in symptom severity, sleep quality, mood, and daily functioning to determine whether cannabinoid-based therapy offers a viable alternative or adjunctive treatment for RLS. Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jacquelyn Bainbridge; Phone Number: 303-810-4254; Email: Jacci.Bainbridge@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female subjects between 18 and 79 years of age, inclusive.
2. Willing and able to give informed consent.
3. Idiopathic RLS, meeting all 4 International RLS Study Group diagnostic criteria.
4. Moderate or severe symptoms, defined as an IRLS score ≥ 15 at screening visit.
5. RLS medications unchanged for 4 weeks prior to baseline.
6. 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.
7. Has a significant other, caregiver, or close acquaintance who knows the subject well and agrees to participate in the subject's neuropsychiatric assessment.
8. Agrees to not take more than 1 gram per day of acetaminophen.
9. Whereas applicable, agrees to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment.

Exclusion Criteria:

1. Secondary RLS, such as Parkinson's disease or end-stage renal disease.
2. Present or past history of another severe sleep disorder.
3. Currently on night shift work schedule.
4. 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.
5. Current suicidal ideation.
6. Severe cognitive impairment (e.g., Alzheimer's Disease, traumatic brain injury).
7. Uncontrolled hypertension.
8. Known or suspected allergy or hypersensitivity to cannabinoids or excipients used in the study drug formulation.
9. Pending legal action or workers compensation.
10. Cannabis use (THC) detectable at the screening/baseline visits.
11. History of drug or alcohol dependence.
12. Use of dopamine blockers, cocaine, or MAO-A inhibitors within 90 days of baseline.
13. 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.
14. Unstable medical condition.
15. Clinically significant laboratory abnormalities.
16. Moderate or severe hepatic impairment.
17. Is pregnant, lactating, or has a positive pregnancy test result pre-dose.
18. Planned elective surgery during study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Oral solution of mono-, di-, and triglycerides
Experimental: BRC-002; 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; 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).; Other Names: Cannabidiol Formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To examine the effect of BRC-002 on RLS symptoms assessed through changes from baseline in RLS-6 Severity Scale	The RLS-6 Severity Scale ranges from 0-60; increasing scores indicates a worse outcome.	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)	The International Restless Legs Syndrome Study Group Rating Scale (IRLS) measures RLS symptoms. Scores range from 0 to 40, with higher scores indicating a worse outcome.	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	The SleepImage Recorder ring measures quality of sleep. Scores range from 0 to 100, with higher scores indicating a better outcome.	Baseline; Day 20
To examine the effect of BRC-002 on RLS symptoms assessed through changes in the Pittsburgh Sleep Quality Index (PSQI).	The Pittsburg Sleep Quality Index (PSQI) measures sleep quality. Scores range from 0 to 21, with higher scores indicating a worse outcome.	Baseline; Day 20
To examine the effect of BRC-002 in sleep measured by change in the Epworth Sleepiness Scale (ESS)	The Epworth Sleepiness Scale (ESS)measures daytime sleepiness. Scores range from 0 to 24, with higher scores indicating a worse outcome.	Baseline; Day 20
To examine the effect of BRC-002 on RLS symptoms assessed through changes in the Fatigue Severity Scale (FSS).	The Fatigue Severity Scale (FSS) measures fatigue. Scores range from 9 to 63, with higher scores indicating a worse outcome.	Baseline; Day 20
To examine the effect of BRC-002 in cognition measured by change in the Montreal Cognitive Assessment (MoCA)	The Montreal Cognitive Assessment (MoCA) measures cognitive impairment. Scores range from 0 to 30, with higher scores indicating a better outcome.	Baseline; Day 20
To examine the effect of BRC-002 in psychiatric symptoms measured by change in the Neuropsychiatric Inventory (NPI) assessment.	Neuropsychiatric Inventory (NPI) measures behavior. Scores range from 0 to 144, with higher scores indicating a worse outcome.	Baseline; Day 20
To examine the effect of BRC-002 in mood measured by change in the Emotional and Behavioral Dyscontrol Short Form.	The Quality of Life in Neurological Disorders Measurement System (Neurol-QOL) measures mood. Scores range from 0 to 100, with higher scores indicating a better outcome.	Baseline; Day 20
To examine the effect of BRC-002 on RLS symptoms assessed through changes in Patient Reported Outcome Measurement Information System (PROMIS).	Patient Reported Outcome Measurement Information System (PROMIS) measures pain. Scores range from 0 to 100, with higher scores indicating a worse outcome.	Baseline; Day 20
To examine the effect of BRC-002 in suicidality measured by change in the Columbia-Suicide Severity Rating Scale (C-SSRS).	The C-SSRS measures suicidality in participants. The scores range from 2 through 25; with higher scores indicating worse outcomes.	Baseline; Day 20
To examine the effect of BRC-002 on RLS symptoms assessed through changes in Clinical Global Impression (CGI) Scales	Clinical Global Impression (CGI) Scales measures improvement in RLS. Scores range from 0 to 7, with higher scores indicating a worse outcome.	Baseline; Day 20
To examine the effect of BRC-002 on RLS symptoms assessed through changes in Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL).	The Johns Hopkins Restless Legs Syndrome Quality of Life Questionnaire (RLSQoL) measures severity of RLS symptoms. Scores range from 0 to 72; with higher scores indicating better outcomes.	Baseline; Day 20

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Biopharmaceutical Research Company; BRC Therapeutics
• Investigators: Principal Investigator: Jacquelyn Bainbridge, Skaggs School of Pharmacy

Study record dates

Study Major Dates

• Study Start (Estimated): December 19, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 25, 2026

Study Registration Dates

• First Submitted: October 6, 2025
• First Submitted That Met QC Criteria: November 3, 2025
• First Posted (Estimated): November 5, 2025

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: cannabis; Restless Leg Syndrome; BRC-002
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Parasomnias; Marijuana Abuse; Restless Legs Syndrome
• Other Study ID Numbers: 23-0682

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No