Phase 4 Study of Topical Cannabidiol Roll-On Canvert-M for Treating Migraine Attacks in Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the efficacy and safety of Canvert-M, a topical roll-on containing cannabidiol and various essential oils, in adults aged 18 to 55 years diagnosed with migraine according to the International Classification of Headache Disorders, 3rd edition ICHD-3. This phase IV, single-arm, open-label clinical trial focuses on reducing headache intensity during migraine attacks using a 4-point scale from no headache to severe headache. Additional measures of effectiveness and safety are also assessed. Participants apply Canvert-M to specific areas including the forehead, temples, behind the ears, and base of the neck at the onset of a migraine attack. If headache persists after 30 minutes, a second dose may be used. Participants record the date and severity of headaches before and at multiple time points after application, avoiding other pain relievers for two hours when possible. They also provide a general evaluation of the treatments effectiveness using a simple verbal scale. Throughout the study, participants track headache severity at baseline and at 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after using Canvert-M. Researchers monitor the need for additional medication, overall treatment satisfaction, and any adverse events up to 30 days from screening. The primary outcome is the percentage of participants reporting at least one level of improvement in headache pain two hours after treatment before any rescue medication is used.

Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks