RecruitingPhase 4NCT07093138

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

Sponsor

Alasht Pharmed

Enrollment

30 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Migraine Disorders

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria7

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 Criteria11

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

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Interventions

COMBINATION_PRODUCTCanvert-M (Produced by Alasht Pharmed co. Iran)

Canvert-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.