drugset / Trial / NCT05961501

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

NCT05961501 ↗

Phase 2/3 Enrolling by invitation 42 enrolled Wroclaw Medical University
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-04-01
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject CBD Unknown — Oral
Subject CBN Unknown — Oral