Canvert-M (manufactured by Alasht Pharmed Co. Iran) is a topical roll-on formulation that contains cannabidiol, peppermint, lavender, rosemary, eucalyptus, wintergreen, basil oil, etc. This phase IV, single-arm, open-label clinical trial evaluated the efficacy and safety of Canvert-M in males and females aged 18 to 55 years diagnosed with migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3), for the treatment of migraine attacks.
The primary objective was to assess the reduction in headache intensity using a 4-point scale (0=no headache, 1=mild headache, 2=moderate headache, 3=severe headache).
Secondary objectives included evaluating additional efficacy and safety outcomes of Canvert-M in managing migraine attacks.
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
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
Single group
Canvert-M (Produced by Alasht Pharmed co. Iran)
Combination productCanvert-M is a topical roll-on formulation that contains cannabidiol, peppermint, lavender, rosemary, eucalyptus, wintergreen, basil oil, etc. At the onset of a migraine attack, an adequate amount of Canvert-M roll-on should be applied to the areas of the forehead, temporal, behind the ears, and the base of the neck. If the patient's headache persists after 30 minutes, a second dose can be used.
The percentage of participants who report improvement in headache pain by at least one severity level (according to the 4-point scale) at 2 hours after treatment, and before the use of any rescue medication.
4-point scale: 0=no headache, 1=mild headache, 2=moderate headache, 3=severe headache
The percentage of participants who report improvement in headache pain by at least one severity level according to the 4-point scale at 1 hour and 24 hours after treatment compared to pretreatment pain
4-point scale: 0=no headache, 1=mild headache, 2=moderate headache, 3=severe headache
The percentage of subjects who need rescue medication 2 hours after treatment
The global evaluation of treatment efficacy based on a simple Likert-type verbal scale asked from the participants
Likert-type verbal scale: Very poor, Poor, No opinion, Good, Very good
Safety assessment by evaluation of adverse events (AEs)
Adverse events (AEs) were assessed at all visits. All reported events were classified as mild, moderate, or severe. Moreover, seriousness of AEs was assessed according to International Council for Harmonization (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.
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