Topical cannabidiol (Canvert-M) for migraine attacks
Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks
This will test whether applying Canvert-M, a topical roll-on with cannabidiol and essential oils, can reduce pain during migraine attacks in adults aged 18–55.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Alasht Pharmed Industry-sponsored |
| Locations | 1 site (Tehran) |
| Trial ID | NCT07093138 on ClinicalTrials.gov |
What this trial studies
This phase IV, single-arm, open-label study enrolled adults 18–55 with ICHD-3–diagnosed migraine who experience 2–8 attacks per month. Participants applied Canvert-M roll-on to the forehead, temples, behind the ears and base of the neck at migraine onset and could use a second dose after 30 minutes if pain persisted. Headache severity was recorded on a 0–3 scale before application and at 30, 60, 120 minutes, 4 hours, and 24 hours after application, with other analgesics discouraged for the first two hours and any rescue medications recorded. Safety and additional efficacy measures, including a patient global effectiveness rating, were also collected.
Who should consider this trial
Good fit: Adults aged 18–55 with a ≥1-year history of migraine diagnosed by ICHD-3, experiencing 2–8 attacks per month and stable on any prophylactic medication are the intended participants.
Not a fit: Patients with chronic migraine, other primary or secondary headache disorders, resistant/refractory migraine, recent use of abortive medication within 48 hours, or who cannot refrain from rescue meds may be unlikely to benefit or be ineligible.
Why it matters
Potential benefit: If effective, Canvert-M could offer a topical, non-oral option to reduce migraine pain with potentially fewer systemic effects.
How similar studies have performed: Evidence is limited and mixed: small studies suggest some benefit from topical essential oils and some cannabinoid formulations, but topical cannabidiol for acute migraine has not been robustly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: 1. Males and females with age of 18 to 55 years 2. Age of migraine onset ˂ 50 years 3. Having a diagnosis of migraine according to the International Classification of Headache Disorders 3rd edition (ICHD-3) for at least one year 4. Having a history of 2-8 attacks per month 5. Remaining stable on prophylactic medication (if used) during the 2 months prior to screening and throughout the study period 6. Using effective contraception by the women of childbearing potential during the study 7. Ability to provide written, informed consent and to be compliant with the schedule of protocol assessments Exclusion criteria: 1. Having a diagnosis of other primary (cluster and tension) and secondary headache disorders 2. Having a history of chronic migraine headache 3. History of resistant or refractory migraine headaches based on European Headache Federation consensus 4. Receiving any abortive medication for the treatment of migraine within 48 hours before using Canvert-M 5. History of psychiatric and neurologic disorders (except migraine) or any medical comorbid conditions that interfere with the study results 6. History of nasal sensitivity or allergy to menthol, lavender, rosemary, eucalyptus, wintergreen and basil oil 7. The presence of any skin lesions in the areas where the product is used 8. Treatment with any investigational agent within 30 days prior to screening 9. History of substance use disorders 10. Nursing mothers, pregnant women, and women who plan to become pregnant during the study period 11. 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 this trial is running
Tehran
- Tehran Province, Tehran, Imam Khomeini Street (RA) - Before Hassan Abad Square — Tehran, Iran (Recruiting)
Study contacts
- Study coordinator: Hamidreza Kafi Hamidreza Kafi,PHD
- Email: kafi.H@orchidpharmed.com
- Phone: +982143473000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.