Tolerability and Efficacy of CBD Extract for RLS Treatment

November 11, 2025 updated by: University of Colorado, Denver

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: Baseline, Visit 3, Visit 4, Visit 5

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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Baseline; Day 20
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)
Time Frame: Baseline; Day 20
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
Time Frame: Baseline; Day 20
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).
Time Frame: Baseline; Day 20
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)
Time Frame: Baseline; Day 20
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).
Time Frame: Baseline; Day 20
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)
Time Frame: Baseline; Day 20
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.
Time Frame: Baseline; Day 20
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.
Time Frame: Baseline; Day 20
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).
Time Frame: Baseline; Day 20
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).
Time Frame: Baseline; Day 20
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
Time Frame: Baseline; Day 20
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).
Time Frame: Baseline; Day 20
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biopharmaceutical Research Company
BRC Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jacquelyn Bainbridge, Skaggs School of Pharmacy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 19, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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