๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion criteria:
1. Males and females with age of 18 to 55 years
2. Age of migraine onset ห 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
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What it tests
- Canvert-M (Produced by Alasht Pharmed co. Iran)
Tehran Province, Tehran, Imam Khomeini Street (RA) - Before Hassan Abad Square
Tehran, Iran
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.
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