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Tolerability and Efficacy of CBD Extract for RLS Treatment

NCT07224932 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-11-13

No results posted yet for this study

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

Interventions

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).

DRUG

Placecbo

Oral solution of mono-, di-, and triglycerides

Sponsors & Collaborators

  • BRC Therapeutics

    collaborator UNKNOWN

  • Biopharmaceutical Research Company

    collaborator UNKNOWN

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Jacquelyn Bainbridge · Skaggs School of Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-19
Primary Completion
2026-01-01
Completion
2026-02-25
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07224932 on ClinicalTrials.gov