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Tolerability and Efficacy of CBD Extract for RLS Treatment

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 2 months later Jan 1, 2026 → Mar 14, 2028
See other at-risk trials from University of Colorado, Denver

Record History

  1. Primary completion pushed from Jan 1, 2026 to Mar 14, 2028 Start date: Dec 19, 2025 to Nov 1, 2026 · Completion pushed from Feb 25, 2026 to Jun 1, 2028 · Study sites: 0 to 1 · 2 more Show 5 more changesShow less
    • Start date: Dec 19, 2025 to Nov 1, 2026
    • Completion pushed from Feb 25, 2026 to Jun 1, 2028
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: 13 to 8
  2. Primary endpoint revised Secondary endpoints revised (13)v2 Show 1 more changeShow less
    • Secondary endpoints revised (13)

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07224932
Lead Sponsor University of Colorado, Denver
Collaborators: Biopharmaceutical Research Company
Conditions Restless Leg Syndrome
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov