NCT07093138RecruitingPhase 4
Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks
Source: ClinicalTrials.gov · Last updated 30 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 20 Jul 2025
- Start date
- 16 Jul 2025
- Primary completion date
- 16 Sept 2025
- Lead sponsor
- Alasht Pharmed
- Diseases
- Migraine
- NCT number
- NCT07093138
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 16 Jul 2025 to the primary completion date, 16 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Receiving any abortive medication for the treatment of migraine within 48 hours before using Canvert-M
- Treatment with any investigational agent within 30 days prior to screening
Other illness
- 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
- 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
- History of substance use disorders
Other
- The presence of any skin lesions in the areas where the product is used
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tehran Province, Tehran, Imam Khomeini Street (RA) - Before Hassan Abad Square Coordinator of this site? Confirm its status | Tehran | Iran | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.