Tolerability and Efficacy of CBD Extract for RLS Treatment
NCT ID: NCT07224932
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-12-19
2026-02-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Comparator
Half of the patients will be randomized to receive placebo orally. It is an oral solution of mono-, di-, and triglycerides
Placecbo
Oral solution of mono-, di-, and triglycerides
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.
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).
Interventions
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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).
Placecbo
Oral solution of mono-, di-, and triglycerides
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
79 Years
ALL
No
Sponsors
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Biopharmaceutical Research Company
UNKNOWN
BRC Therapeutics
UNKNOWN
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Jacquelyn Bainbridge
Role: PRINCIPAL_INVESTIGATOR
Skaggs School of Pharmacy
Central Contacts
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Other Identifiers
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23-0682
Identifier Type: -
Identifier Source: org_study_id