Actively Recruiting

Phase 4
Age: 18Years - 55Years
All Genders
NCT07093138

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

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females aged 18 to 55 years
  • Migraine diagnosis according to the International Classification of Headache Disorders 3rd edition (ICHD-3) for at least one year
  • Onset of migraine before age 50
  • History of 2 to 8 migraine attacks per month
  • Stable use of any migraine preventive 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 procedures
Not Eligible

You will not qualify if you...

  • Diagnosis of other primary (cluster or tension) or secondary headache disorders
  • History of chronic migraine headaches
  • History of resistant or refractory migraine headaches
  • Use of any abortive migraine medication within 48 hours before using Canvert-M
  • History of psychiatric or neurological disorders other than migraine, or medical conditions interfering with study results
  • Allergy or sensitivity to menthol, lavender, rosemary, eucalyptus, wintergreen, or basil oil
  • Presence of skin lesions where Canvert-M would be applied
  • Treatment with any investigational drug within 30 days before screening
  • History of substance use disorders
  • Nursing mothers, pregnant women, or women planning pregnancy during the study
  • Use of certain medications (e.g., carbamazepine, citalopram, warfarin) within 14 days before study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Tehran, Iran

Actively Recruiting

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Research Team

H

Hamidreza Kafi Hamidreza Kafi,PHD

CONTACT

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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