Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks

Обзор

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.

Подробное описание

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.

Вмешательства

• Комбинированный продукт 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.

Первичные конечные точки

• 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. [Срок оценки: Pre-treatment and 2 hours after treatment]

Вторичные конечные точки (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 [Срок оценки: Pre-treatment, 1 hour and 24 hours after treatment]
• The percentage of subjects who need rescue medication 2 hours after treatment [Срок оценки: 2 hours after treatment]
• The global evaluation of treatment efficacy based on a simple Likert-type verbal scale asked from the participants [Срок оценки: 24 hours after treatment]
• Safety assessment by evaluation of adverse events (AEs) [Срок оценки: From the screening visit and for up to 30 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Иран · 1 центр

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

Идентификаторы

NCT: NCT07093138 · CANM.ALA.MT.IV.O3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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