Restless Leg SyndromePhase 2NCT07224932
Tolerability and Efficacy of CBD Extract for RLS Treatment
A Phase 2 study testing BRC-002 and Placecbo in people with Restless Leg Syndrome, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Restless Leg Syndrome
- What is being tested?
- BRC-002 and Placecbo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
- Moderate or severe hepatic impairment.
- Is pregnant, lactating, or has a positive pregnancy test result pre-dose.
- Planned elective surgery during study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Colorado Clinical and Translational Sciences Institute (CCTSI) - Anschutz Medical Campus
Aurora, Colorado, 80045
Jacquelyn Bainbridge, PharmD, 303-724-2617, JACCI.BAINBRIDGE@CUANSCHUTZ.EDU
About this study
Official title: 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.
Read the 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.
- Conditions
- Restless Leg Syndrome
- Being tested
- BRC-002, Placecbo
- Keywords
- Restless Leg Syndrome, cannabis, BRC-002
- Medical subject headings
- Restless Legs Syndrome, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BRC-002Drug
Also called Cannabidiol Formulation
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).
PlacecboDrug
Oral solution of mono-, di-, and triglycerides
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: BRC-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Visit 3, Visit 4, Visit 5
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; Day 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2025
- Study start1 Nov 2026 (estimated)
- Primary completion14 Mar 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Leg SyndromeStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Biopharmaceutical Research Company
- Responsible party
- Sponsor
- Investigators
- Jacquelyn Bainbridge, Principal investigator, Skaggs School of Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224932
- Sponsor's protocol ID
- 23-0682
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07224932
- Acronym / sponsor ID
- 23-0682
- Conditions
- Restless Leg Syndrome
- Keywords
- Restless Leg Syndrome, cannabis, BRC-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Biopharmaceutical Research Company
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 14 Mar 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 5 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Drug: PlacecboHalf of the patients will be randomized to receive placebo orally. It is an oral solution of mono-, di-, and triglycerides |
| BRC-002 | Experimental | Drug: BRC-002Half 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BRC-002Also: Cannabidiol FormulationBRC-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). | Drug | BRC-002 |
| PlacecboOral solution of mono-, di-, and triglycerides | Drug | Placebo Comparator |
Primary outcome
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.
8 secondary outcomes
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
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
To examine the effect of BRC-002 in sleep measured by change in the Epworth Sleepiness Scale (ESS)
Time frame: 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
To examine the effect of BRC-002 in cognition measured by change in the Montreal Cognitive Assessment (MoCA)
Time frame: 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
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
To examine the effect of BRC-002 on RLS symptoms assessed through changes in Clinical Global Impression (CGI) Scales
Time frame: Baseline; Day 20
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Restless Leg Syndrome
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Functional Connectivity of the Interoceptive Network in RLS
Restless Legs Syndrome
Not yet recruitingPhase 2
Intravenous Iron in the Management of Drug-resistant Restless Legs syndromeI
Restless Legs Syndrome (RLS)
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The Effect of Acupressure on Restless Legs Syndrome and Pruritus in Patients Undergoing Hemodialysis
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Not yet recruiting
Efficacy and Safety of Super High-Flux Hemodialysis in Maintenance Dialysis Patients. SHINE-RLS (Super High-flux Dialysis Improves Neuro-symptoms and Efficacy in Restless Legs Syndrome)
End Stage Renal Failure, Hemodialysis, Restless Leg Syndrome (RLS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jacquelyn Bainbridge principal investigator
Skaggs School of Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BRC-002 and Placecbo in people with Restless Leg Syndrome, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacquelyn Bainbridge (303-810-4254, Jacci.Bainbridge@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.