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

In this study, participants are asked to:

• Apply an adequate amount of Canvert-M roll-on to the areas of the forehead, temporal, behind the ears, and base of the neck, at the onset of a migraine attack. (If the participant's headache persists after 30 minutes, a second dose can be used.)
• Record the date when the headache occurred.
• Record the severity of the headache at various time points (before using Canvert-M, and then at 30 minutes, 60 minutes, 120 minutes, 4 hours, and 24 hours after using the Canvert-M roll-on) based on the 4-point scale.
• As much as possible, avoid using any other analgesics for two hours after applying Canvert-M. However, if the headache persists after two hours, the participant may use another medication and should record the name(s) of the drug(s) taken.
• Record a general evaluation of the effectiveness of the investigational product using a simple Likert-type verbal scale.

Inclusion criteria

• Males and females with age of 18 to 55 years
• Age of migraine onset ˂ 50 years
• Having a diagnosis of migraine according to the International Classification of Headache Disorders 3rd edition (ICHD-3) for at least one year
• Having a history of 2-8 attacks per month
• Remaining stable on prophylactic medication (if used) during the 2 months prior to screening and throughout the study period
• Using effective contraception by the women of childbearing potential during the study
• Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments

Exclusion criteria

• Having a diagnosis of other primary (cluster and tension) and secondary headache disorders
• Having a history of chronic migraine headache
• History of resistant or refractory migraine headaches based on European Headache Federation consensus
• Receiving any abortive medication for the treatment of migraine within 48 hours before using Canvert-M
• History of psychiatric and neurologic disorders (except migraine) or any medical comorbid conditions that interfere with the study results
• History of nasal sensitivity or allergy to menthol, lavender, rosemary, eucalyptus, wintergreen and basil oil
• The presence of any skin lesions in the areas where the product is used
• Treatment with any investigational agent within 30 days prior to screening
• History of substance use disorders
• Nursing mothers, pregnant women, and women who plan to become pregnant during the study period
• Taking carbamazepine, cilostazol, citalopram, clarithromycin, clobazam, colchicine, cyclosporine, digoxin, itraconazole, phenobarbital, phenytoin, rifampin, sirolimus, tacrolimus, tizanidine, and warfarin within 14 days of the study procedure