Tests cannabidiol doses for preventing chronic migraine headaches
Compares two cannabidiol doses with a placebo in adults with chronic migraine.
Plain-language title generated from the registry record
Registry title: Cannabis for the Prophylactic Treatment of Migraine
Key facts
- Where
- Calgary, CanadaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 25 or older with chronic migraine who have already tried at least 2 migraine preventive medicines without enough benefit or without being able to tolerate them.
- Age
- 25 years or older
- Sex
- Men and women
- Disease stage
- Migraine for at least 12 months, and chronic migraine for at least the 3 months before screening, as defined by ICHD-3.
- Earlier treatment
- Must have tried at least 2 migraine preventive medicines that did not work or were not tolerated. Current preventive medicines, including Botulinum toxin injections, are allowed if the dose has been stable for 3 months and will not change during the study.
Main reasons for not taking part
- Other active primary headaches, or any secondary headache
- Pregnant, planning to become pregnant, or breastfeeding
- Major mental illness, any psychosis or schizophrenia, or substance use disorder
- Regular cannabis use in the previous 12 months
- Heart or brain blood vessel disease, seizure disorder, or liver or severe kidney disease
Read by machine on 12 November 2026.
Where in Canada
- CHAMP Research (Calgary Headache Assessment & Management Program)Calgary, CanadaContact: CHAMP Research (Calgary Headache Assessment & Management Prog)Taking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University of Calgary
- Trial code
- NCT03972124
- Record updated
- 1 May 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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; Any secondary headache, such as headache related to intracranial hypertension, intracranial hypotension, hydrocephalus, intracranial mass lesion, etc; 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; 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; 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; Severe renal disease or GFR more than 30% below expected; Other active primary headaches, such as cluster headache, hemicrania continua, etc; Pregnant, planning to become pregnant, or breastfeeding.