Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks
Recruiting · NCT07093138 · Interventional (participants receive a specific treatment) · Lead sponsor: Alasht Pharmed
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Tehran Province, Tehran, Imam Khomeini Street (RA) - Before Hassan Abad Square - Tehran, Iran