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Clinical Trials in Poland / NCT05961501
Enrolling by invitation Phase 2/3

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

NCT05961501 · tracked via the Priya Life Science Poland tracker
Sponsor
Wroclaw Medical University
Phase
Phase 2/3
Started
2025-04-01
Last updated
2026-03-06

Condition(s) studied

MyalgiaMuscle PainOrofacial PainHeadache, TensionHeadaches MuscularHeadache

Investigational drug(s) / intervention(s)

An aqueous solution containing CBD and CBNThe aqueous solution of placebo

An aqueous solution containing CBD and CBN: An aqueous solution containing CBD and CBN, to drink at home in the dose determined by the attending physician

The aqueous solution of placebo: An aqueous solution of placebo, to drink at home in the dose determined by the attending physician

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * facial pain and headache of muscular origin for more than 3 months Exclusion Criteria: * patients under 18 years of age, * patients who are allergic to any ingredient of the preparation, * pregnant or breast-feeding women, * patients taking preparations that contain similar ingredients and/or have similar effects, * obese patients, * patients with active cancer, * patients with severe systemic diseases, including genetic and neurological diseases, * patients with severe mental illnesses, * patients who are taking or in the last 12 months have taken antidepressants and/or myorelaxants and/or other drugs that affect neuromuscular activity, * patients addicted to alcohol or drugs.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Wroclaw Medical University Wroclaw Poland

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Other trials for the same condition

Concentration of Receptors With Affinity for Cannabidiol and Cannabinol and the Effect on Chronic Orofacial Pain of Muscle Origin Enrolling by invitation
Autologous Exosomes From Platelet-rich Plasma as a Modern Tool of Regenerative Dentistry Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05961501 on ClinicalTrials.gov ↗ ← All trials in Poland