NCT07093138招募中4 期
Evaluation of Efficacy and Safety of Topical Cannabidiol (Canvert-M Produced by Alasht Pharmed co. Iran) in the Treatment of Migraine Attacks
Alasht Pharmed1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月16日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: Pre-treatment and 2 hours after treatment
4-point scale: 0=no headache, 1=mild headache, 2=moderate headache, 3=severe headache
次要结局
- The global evaluation of treatment efficacy based on a simple Likert-type verbal scale asked from the participants(24 hours after treatment)
- The percentage of subjects who need rescue medication 2 hours after treatment(2 hours after treatment)
- 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(Pre-treatment, 1 hour and 24 hours after treatment)
- Safety assessment by evaluation of adverse events (AEs)(From the screening visit and for up to 30 days)
研究者
研究点 (1)
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