Cannabis for the Prophylactic Treatment of Migraine

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Calgary

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Other active primary headaches, such as cluster headache, hemicrania continua, etc.

• Any secondary headache, such as headache related to intracranial hypertension, intracranial hypotension, hydrocephalus, intracranial mass lesion, etc.

• Pregnant, planning to become pregnant, or breastfeeding.

• Active or significant history of major mental illness, including severe depression, or anxiety, and any history of psychosis or schizophrenia.

• History of or current substance use disorder.

• Regular use of cannabis for medical or recreational reasons during the previous 12 months.

• History of significant cardiovascular or cerebrovascular disease, such as previous myocardial infarction, stroke, or peripheral vascular disease.

• History of hypertension greater than 160/100 and not medically treated.

• Any past history of seizure disorder.

• Liver disease or liver enzymes two or more times the upper limit of normal at baseline.

• Severe renal disease or GFR more than 30% below expected.

• Any disorder or condition leading to hypersomnolence or excessive daytime drowsiness, such as narcolepsy, excessive use of sedatives/hypnotics, etc.

• Any other medical condition that in the opinion of the investigators may pose a health risk to the subject if entered into the clinical trial.

• Use of interventions or devices, such as nerve blocks, sphenopalatine ganglion blocks, vagal nerve stimulators, and transcranial magnetic stimulators during the baseline period (weeks -4 to 0). These treatments will also be prohibited during the period of therapy (weeks 0 to 12).

• Use of transitional therapies such as a course of steroids or a dihydroergotamine protocol during the baseline period (weeks -4 to 0). These treatments will also be prohibited during the period of therapy (weeks 0 to 12).

• Overuse of triptan, dihydroergotamine, opioid, or barbiturate medications, defined as 10 or more days per month in the 3 months prior to randomization.

• Overuse of simple analgesics (such as acetaminophen, ibuprofen, aspirin), and non-steroidal anti-inflammatories (such as naproxen, ketorolac, diclofenac, etc.) defined as 15 or more days per month in the 3 months prior to randomization.