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

Recruiting now · Phase 4

Conditions studied: Migraine Disorders

In brief

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.

Key facts

Study ID

NCT07093138

Run by

Alasht Pharmed

People needed

30

Starts

2025-07-16

Expected to finish

2025-09-16

Last updated by the study team

2025-07-30

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Tehran Province, Tehran, Imam Khomeini Street (RA) - Before Hassan Abad Square — Tehran, Iran (enrolling)

Full record on ClinicalTrials.gov

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