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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAlasht Pharmed

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Canvert-M (Produced by Alasht Pharmed co. Iran)

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

1
Tehran Province, Tehran, Imam Khomeini Street (RA) - Before Hassan Abad Square Tehran Iran

Sponsors and collaborators

Alasht Pharmed

Lead sponsor