Actively Recruiting
Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks
Led by Alasht Pharmed · Updated on 2025-07-30
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Canvert-M, a topical roll-on containing cannabidiol and various essential oils, in adults aged 18 to 55 years diagnosed with migraine according to the International Classification of Headache Disorders, 3rd edition (ICHD-3). This phase IV, single-arm, open-label clinical trial focuses on reducing headache intensity during migraine attacks using a 4-point scale from no headache to severe headache. Additional measures of effectiveness and safety are also assessed. Participants apply Canvert-M to specific areas including the forehead, temples, behind the ears, and base of the neck at the onset of a migraine attack. If headache persists after 30 minutes, a second dose may be used. Participants record the date and severity of headaches before and at multiple time points after application, avoiding other pain relievers for two hours when possible. They also provide a general evaluation of the treatment's effectiveness using a simple verbal scale. Throughout the study, participants track headache severity at baseline and at 30 minutes, 1 hour, 2 hours, 4 hours, and 24 hours after using Canvert-M. Researchers monitor the need for additional medication, overall treatment satisfaction, and any adverse events up to 30 days from screening. The primary outcome is the percentage of participants reporting at least one level of improvement in headache pain two hours after treatment before any rescue medication is used.
CONDITIONS
Brief Title
Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 to 55 years
- Migraine onset age less than or equal to 50 years
- Diagnosis of migraine according to ICHD-3 for at least one year
- History of 2 to 8 migraine attacks per month
- Stable on prophylactic medication for at least 2 months before screening and during the study
- Women of childbearing potential must use effective contraception during the study
- Ability to provide written informed consent and comply with study assessments
You will not qualify if you...
- Diagnosis of other primary (cluster and tension) or secondary headache disorders
- History of chronic migraine headache
- History of resistant or refractory migraine headaches
- Use of abortive migraine medication within 48 hours before Canvert-M application
- History of psychiatric or neurological disorders other than migraine or medical conditions interfering with study results
- Nasal sensitivity or allergy to menthol, lavender, rosemary, eucalyptus, wintergreen, or basil oil
- Presence of skin lesions where the product would be applied
- Use of investigational drugs within 30 days before screening
- History of substance use disorders
- Nursing mothers, pregnant women, or women planning pregnancy during the study
- Use of specific medications (e.g., carbamazepine, citalopram, warfarin) within 14 days of study procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies depending on migraine attacks experienced during the study period
Participants apply the Canvert-M topical roll-on at the onset of a migraine attack, with a possible second dose after 30 minutes if the headache persists. They record headache severity at multiple time points and avoid other analgesics for two hours following application.
Participants record symptoms and medication use at each migraine attack; no scheduled visits required during treatment
Duration - Up to 30 days
Participants are monitored for safety and adverse events for up to 30 days after screening.
Safety assessments conducted during the study period; visit schedule varies
Trial Site Locations
Total: 1 location
1
Tehran Province, Tehran, Imam Khomeini Street (RA) - Before Hassan Abad Square
Tehran, Iran
Actively Recruiting
Research Team
H
Hamidreza Kafi Hamidreza Kafi,PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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