Canvert-M (manufactured by Alasht Pharmed Co. Iran) is a topical roll-on formulation thatcontains cannabidiol, peppermint, lavender, rosemary, eucalyptus, wintergreen, basil oil,etc. This phase IV, single-arm, open-label clinical trial evaluated the efficacy andsafety of Canvert-M in males and females aged 18 to 55 years diagnosed with migraineaccording 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-pointscale (0=no headache, 1=mild headache, 2=moderate headache, 3=severe headache).Secondary objectives included evaluating additional efficacy and safety outcomes ofCanvert-M in managing migraine attacks.
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.
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. If the patient's headache
persists after 30 minutes, a second dose can be used.
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
Tehran Province, Tehran, Imam Khomeini Street (RA) - Before Hassan Abad Square
Tehran, Iran, Islamic Republic of
Investigator: Mansoureh Togha
Contact: 02166348500
Togha1961@gmail.com
Hamidreza Kafi Hamidreza Kafi,PHD
+982143473000
kafi.H@orchidpharmed.com
Not Provided