Cannabis for the Prophylactic Treatment of Migraine: a Randomized Double-Blind Placebo-Controlled Clinical Trial
This study will evaluate the efficacy and safety of cannabis for the treatment of chronic migraine headaches. Study subjects will be randomized to one of three groups: lower dose CBD, higher dose CBD or placebo.
• Subject is willing and able to give signed informed consent.
• Male and female patients aged 25 years or older.
• History of migraine for at least 12 months as diagnosed by the International Classification of Headache Disorders (ICHD-3).
• Chronic migraine for at least the previous 3 months prior to screening, as diagnosed by ICHD-3.
• Migraine preventative medications (including Botulinum toxin injections) are permitted if dose is stable for the 3 month period prior to randomization, and no change to dose is planned for the entire duration of the study.
• Using a reliable method of contraception for females of child-bearing age.
• Failure of at least 2 prior migraine preventatives, either due to lack of efficacy with an appropriate trial of the medication, or due to lack of tolerability.
• Able to follow study procedures, fill out headache diaries, and complete questionnaires.
• Completion of at least 90% of the headache diary during the one month baseline period.