Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks

NCT07093138 | Recruiting Phase 4

• 1 other identifier: CANM.ALA.MT.IV.O3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders

Keywords

Cannabidiol; Migraine disorders; Mentha piperita; Lavandula; Eucalyptus; Ocimum basilicum; Rosmarinus; Gaultheria; Headache

Outcome Measures

Primary Outcomes (1)

• The percentage of participants who report improvement in headache pain by at least one severity level (according to the 4-point scale) at 2 hours after treatment, and before the use of any rescue medication.

  4-point scale: 0=no headache, 1=mild headache, 2=moderate headache, 3=severe headache

  Pre-treatment and 2 hours after treatment

Secondary Outcomes (4)

• The percentage of participants who report improvement in headache pain by at least one severity level according to the 4-point scale at 1 hour and 24 hours after treatment compared to pretreatment pain

  Pre-treatment, 1 hour and 24 hours after treatment

• The percentage of subjects who need rescue medication 2 hours after treatment

  2 hours after treatment

• The global evaluation of treatment efficacy based on a simple Likert-type verbal scale asked from the participants

  24 hours after treatment

• Safety assessment by evaluation of adverse events (AEs)

  From the screening visit and for up to 30 days

Study Arms (1)

Canvert-M (Produced by Alasht Pharmed co. Iran)

EXPERIMENTAL

Canvert-M is a topical roll-on formulation that contains cannabidiol, peppermint, lavender, rosemary, eucalyptus, wintergreen, basil oil, etc. At the onset of a migraine attack, an adequate amount of Canvert-M roll-on should be applied to the areas of the forehead, temporal, behind the ears, and the base of the neck.

Combination Product: Canvert-M (Produced by Alasht Pharmed co. Iran)

Interventions

Canvert-M (Produced by Alasht Pharmed co. Iran) COMBINATION_PRODUCT

Canvert-M is a topical roll-on formulation that contains cannabidiol, peppermint, lavender, rosemary, eucalyptus, wintergreen, basil oil, etc. At the onset of a migraine attack, an adequate amount of Canvert-M roll-on should be applied to the areas of the forehead, temporal, behind the ears, and the base of the neck. If the patient's headache persists after 30 minutes, a second dose can be used.

Canvert-M (Produced by Alasht Pharmed co. Iran)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alasht Pharmed: lead

Study Sites (1)

Tehran Province, Tehran, Imam Khomeini Street (RA) - Before Hassan Abad Square

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hamidreza Kafi Hamidreza Kafi,PHD

CONTACT

+982143473000; kafi.H@orchidpharmed.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 30, 2025
• Study Start: July 16, 2025
• Primary Completion: September 16, 2025
• Study Completion: September 16, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)