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

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-16
• Study Completion Date: 2025-09-16

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.

Detailed Description

In this study, participants are asked to:

• Apply an adequate amount of Canvert-M roll-on to the areas of the forehead, temporal, behind the ears, and base of the neck, at the onset of a migraine attack. (If the participant's headache persists after 30 minutes, a second dose can be used.)
• Record the date when the headache occurred.
• Record the severity of the headache at various time points (before using Canvert-M, and then at 30 minutes, 60 minutes, 120 minutes, 4 hours, and 24 hours after using the Canvert-M roll-on) based on the 4-point scale.
• As much as possible, avoid using any other analgesics for two hours after applying Canvert-M. However, if the headache persists after two hours, the participant may use another medication and should record the name(s) of the drug(s) taken.
• Record a general evaluation of the effectiveness of the investigational product using a simple Likert-type verbal scale.

Conditions

Migraine Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alasht Pharmed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Hamidreza Kafi Hamidreza Kafi,PHD

Role: CONTACT

kafi.H@orchidpharmed.com

+982143473000

Facility Contacts

Mansoureh Togha

Role: primary

Togha1961@gmail.com

02166348500

Other Identifiers

CANM.ALA.MT.IV.O3

Identifier Type: -

Identifier Source: org_study_id