NCT07093138 Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks
| NCT ID | NCT07093138 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Alasht Pharmed |
| Condition | Migraine Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-07-16 |
| Primary Completion | 2025-09-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2025-07-16 with a primary completion date of 2025-09-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07093138 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Migraine Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07093138 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07093138 currently recruiting?
Yes, NCT07093138 is actively recruiting participants. Contact the research team at kafi.H@orchidpharmed.com for enrollment information.
Where is the NCT07093138 trial being conducted?
This trial is being conducted at Tehran, Iran.
Who is sponsoring the NCT07093138 clinical trial?
NCT07093138 is sponsored by Alasht Pharmed. The trial plans to enroll 30 participants.
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