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The Effectiveness of CBD and CBN in the Treatment of Facial Pain and Headache of Muscular Origin

StatusEnrolling by Invitation
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2025 to Dec 2026
    • Study completion date: Feb 2026 to Dec 2026
    v5
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Apr 2025 to Apr 1, 2025
    v4
  3. Primary completion date: Dec 2024 to Dec 2025
    • Start date: Jul 2024 to Apr 2025
    • Study completion date: Dec 2025 to Feb 2026
    v3
  4. Start date: Jul 2023 to Jul 2024v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The aim of the study is to evaluate the effectiveness of an aqueous solution containing CBD and CBN in the management of Facial Pain and Headache of Muscular Origin. A randomized (block randomization), double-blind, two-arm controlled trial will involve 42 adult patients diagnosed with Facial Pain and Headache of Muscular Origin which is lasting more than 3 months on the basis of clinical examination. Qualified study participants will be randomly assigned to two groups. The studied group will receive tan aqueous solution containing CBD and CBN, to drink at home in the dose determined by the attending physician, while the control group will receive an aqueous solution of placebo, to drink at home in the dose determined by the attending physician during this time. Each subject will be tested on the qualification day (D0), on 20 days after D0 (D20), and then 40 (D40) and 60 (D60) days after the qualification day using electromyography (EMG), pressure pain threshold test (PPT), clinical examination and surveys.
Trial Details
NCT Number NCT05961501
Lead Sponsor Wroclaw Medical University
Conditions
(from sponsor)		 Myalgia, Muscle Pain, Orofacial Pain, Headache, Tension, Headaches Muscular, Headache
Related terms Facial Pain, Headache, Myalgia, Tension-Type Headache
Enrollment 42 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov