Migraine DisordersPhase 4NCT07093138
Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks
A Phase 4 study testing Canvert-M (Produced by Alasht Pharmed co. Iran) in people with Migraine Disorders, run by Alasht Pharmed at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Migraine Disorders
- What is being tested?
- Canvert-M (Produced by Alasht Pharmed co. Iran)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 16 Jul 2025to 16 Sep 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Tehran Province, Tehran, Imam Khomeini Street (RA) - Before Hassan Abad Square
Tehran
Mansoureh Togha, 02166348500, Togha1961@gmail.com
About this study
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.
Read the 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
- Being tested
- Canvert-M (Produced by Alasht Pharmed co. Iran)
- Keywords
- Cannabidiol, Migraine disorders, Mentha piperita, Lavandula, Eucalyptus, Ocimum basilicum, Rosmarinus, Gaultheria, Headache
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: Canvert-M (Produced by Alasht Pharmed co. Iran) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
4-point scale: 0=no headache, 1=mild headache, 2=moderate headache, 3=severe headache
Measured: Pre-treatment, 1 hour and 24 hours after treatment
The percentage of subjects who need rescue medication 2 hours after treatment
Measured: 2 hours after treatment
The global evaluation of treatment efficacy based on a simple Likert-type verbal scale asked from the participants
Likert-type verbal scale: Very poor, Poor, No opinion, Good, Very good
Measured: 24 hours after treatment
Safety assessment by evaluation of adverse events (AEs)
Adverse events (AEs) were assessed at all visits. All reported events were classified as mild, moderate, or severe. Moreover, seriousness of AEs was assessed according to International Council for Harmonization (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.
Measured: From the screening visit and for up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start16 Jul 2025
- Primary completion16 Sep 2025 (estimated)
- Study completion16 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alasht Pharmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093138
- Sponsor's protocol ID
- CANM.ALA.MT.IV.O3
- Status last verified
- Jul 2025
- First submitted
- 20 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data produced in the present study are available upon reasonable request from the investigators.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks
- ClinicalTrials.gov ID
- NCT07093138
- Acronym / sponsor ID
- CANM.ALA.MT.IV.O3
- Conditions
- Migraine Disorders
- Keywords
- Cannabidiol, Migraine disorders, Mentha piperita, Lavandula, Eucalyptus, Ocimum basilicum, Rosmarinus, Gaultheria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alasht PharmedIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- 16 Sep 2025 (estimated)
- Study completion
- 16 Sep 2025 (estimated)
- First posted
- 30 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Canvert-M (Produced by Alasht Pharmed co. Iran) | Experimental | Combination Product: 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Canvert-M (Produced by Alasht Pharmed co. Iran) |
Primary outcome
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.
Time frame: Pre-treatment and 2 hours after treatment
4-point scale: 0=no headache, 1=mild headache, 2=moderate headache, 3=severe headache
4 secondary outcomes
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
Time frame: Pre-treatment, 1 hour and 24 hours after treatment
The percentage of subjects who need rescue medication 2 hours after treatment
Time frame: 2 hours after treatment
The global evaluation of treatment efficacy based on a simple Likert-type verbal scale asked from the participants
Time frame: 24 hours after treatment
Safety assessment by evaluation of adverse events (AEs)
Time frame: From the screening visit and for up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No. Data produced in the present study are available upon reasonable request from the investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Canvert-M (Produced by Alasht Pharmed co. Iran) in people with Migraine Disorders, run by Alasht Pharmed at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hamidreza Kafi Hamidreza Kafi,PHD (+982143473000, kafi.H@orchidpharmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Pre-treatment and 2 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.