The Evaluation of the Effectiveness of Cannabidiol (CBD) and Cannabinol (CBN) Oral Solutions in the Treatment of Facial Pain and Headache of Muscular Origin

WMU1/2023

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.

2024-07-01

2024-12-01

2025-12-01

Not yet recruiting

Early phase I

42

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 42, 'type': 'ESTIMATED'}}

2024-05-07