Topical cannabidiol (Canvert-M) for migraine attacks

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.