Chronic MigrainePhase 2NCT03972124
Cannabis for the Prophylactic Treatment of Migraine
A Phase 2 study testing CBD 100 mg OD and CBD 200 mg OD in people with Chronic Migraine, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- CBD 100 mg OD and CBD 200 mg OD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
CHAMP Research (Calgary Headache Assessment & Management Prog) contact
Canada1 site, 1 recruiting
- Recruiting
CHAMP Research (Calgary Headache Assessment & Management Program)
Calgary, Alberta, T3M 1M4
CHAMP Research (Calgary Headache Assessment & Management Prog), 403-956-3427 or 403-956-3548, champ.research@ucalgary.ca
About this study
Official title: 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.
Read the detailed description
Migraine is a neurological disorder characterized by recurrent attacks of moderate to severe headache, often accompanied by sensory sensitivity and nausea. Migraine can be very disabling and often interferes with social and occupational functioning.
Given the high prevalence of migraine and the significant burden it places on the individual and society, it is an important condition to study and manage optimally. This is especially true because current migraine treatments often result in only marginal improvement and are frequently associated with intolerable side effects. For this reason, there is a need for new migraine treatments. The endocannabinoid system is an important potential treatment target as it is involved in pain processing and overlaps with some mechanisms of migraine pathophysiology.
Cannabis was legalized in Canada on October 17th, 2018. As a result, the consumption of cannabis products for migraine treatment may increase. However, at this time there is limited evidence for the safety and efficacy of cannabis for the treatment of migraine. As a result, there is a need for further study and research in this area. Thus, we propose a randomized, double-blind, placebo-controlled clinical trial to study cannabis (specifically cannabidiol) as a preventative therapy for patients with chronic migraine.
- Conditions
- Chronic Migraine
- Being tested
- CBD 100 mg OD, CBD 200 mg OD, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD 100 mg ODDrug
CBD oil - purified to <1% THC in soft-gel capsules
CBD 200 mg ODDrug
CBD oil - purified to <1% THC in soft-gel capsules
PlaceboDrug
Soft-gel capsules containing placebo
| Study group | Role | What they receive |
|---|---|---|
| CBD 100 mg OD | Active comparator | The lower dose CBD group will start with CBD capsules 10 mg OD, then increase the dose every 4 days until on the target dose of 100 mg OD. Receives: Drug: CBD 100 mg OD |
| CBD 200 mg OD | Experimental | The higher dose CBD group will start with CBD capsules 10 mg OD and will increase every 4 days until on a target dose of 200 mg OD. Receives: Drug: CBD 200 mg OD |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in the number of headache days between the 4-week baseline period compared to the 4-week period just preceding the 3 month follow-up visit.
Measured: Baseline and weeks 9-12
Secondary outcomes (10)
The mean change in the number of headache days between baseline compared to the 4-week period just preceding the 6 month follow-up visit.
Measured: Weeks -4 to 0 and weeks 21-24
The percentage of patients who have at least a 50% reduction in their headache frequency between baseline compared to weeks 9-12 (the 50% responder rate).
Measured: Weeks -4 to 0 and weeks 9-12
The change in the mean headache intensity between baseline compared to weeks 9-12, and weeks 21-24.
Measured: Weeks -4 to 0, weeks 9-12 and weeks 21-24
The mean change in the number of days with acute pain medication use between baseline compared to weeks 9-12, and 21-24.
Measured: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in Migraine Disability Assessment (MIDAS) Test score between baseline compared to weeks 9-12, and 21-24.
The MIDAS test assesses the impact of migraines on daily life. The score ranges between 0 and 21+ with a lower score indicating little or no disability and a higher score indicating severe disability.
Measured: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in Headache Impact Test (HIT-6) score between baseline compared to weeks 9-12, and 21-24.
The HIT-6 test score ranges between 36-78 with a higher score being associated with greater impact of headache on an individual's life.
Measured: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in Generalized Anxiety Disorder (GAD-7) score between baseline compared to weeks 9-12, and 21-24.
The GAD-7 patient questionnaire is used as a screening tool for generalized anxiety disorder with scores ranging between 0-21. A higher score is associated with a probable diagnosis of severe anxiety.
Measured: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in Patient Health Questionnaire (PHQ-9) score between baseline compared to weeks 9-12, and 21-24.
The PHQ-9 questionnaire is a self-administered screening tool for depression. The questionnaire score can range between 0-27 with higher scores indicating severe depression.
Measured: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in Migraine Specific Quality of Life Questionnaire (MSQ) score between baseline compared to weeks 9-12, and 21-24.
The MSQ assesses the impact (restrictive, preventative and emotional) of migraine on an individual's quality of life.
Measured: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in the Pittsburgh Sleep Quality Index (PSQI) score between baseline compared to weeks 9-12, and 21-24.
The PSQI is a tool used to measure the quality of an individual's sleep. The PSQI is self-administered with a higher score indicating overall poor sleep.
Measured: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Apr 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farnaz Amoozegar, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972124
- Sponsor's protocol ID
- REB19-0889
- Status last verified
- Apr 2026
- First submitted
- 30 May 2019
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabis for the Prophylactic Treatment of Migraine: a Randomized Double-Blind Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03972124
- Acronym / sponsor ID
- REB19-0889
- Conditions
- Chronic Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Migraine is a neurological disorder characterized by recurrent attacks of moderate to severe headache, often accompanied by sensory sensitivity and nausea. Migraine can be very disabling and often interferes with social and occupational functioning.
Given the high prevalence of migraine and the significant burden it places on the individual and society, it is an important condition to study and manage optimally. This is especially true because current migraine treatments often result in only marginal improvement and are frequently associated with intolerable side effects. For this reason, there is a need for new migraine treatments. The endocannabinoid system is an important potential treatment target as it is involved in pain processing and overlaps with some mechanisms of migraine pathophysiology.
Cannabis was legalized in Canada on October 17th, 2018. As a result, the consumption of cannabis products for migraine treatment may increase. However, at this time there is limited evidence for the safety and efficacy of cannabis for the treatment of migraine. As a result, there is a need for further study and research in this area. Thus, we propose a randomized, double-blind, placebo-controlled clinical trial to study cannabis (specifically cannabidiol) as a preventative therapy for patients with chronic migraine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBD 100 mg OD | Active comparator | Drug: CBD 100 mg ODThe lower dose CBD group will start with CBD capsules 10 mg OD, then increase the dose every 4 days until on the target dose of 100 mg OD. |
| CBD 200 mg OD | Experimental | Drug: CBD 200 mg ODThe higher dose CBD group will start with CBD capsules 10 mg OD and will increase every 4 days until on a target dose of 200 mg OD. |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBD 100 mg ODCBD oil - purified to <1% THC in soft-gel capsules | Drug | CBD 100 mg OD |
| CBD 200 mg ODCBD oil - purified to <1% THC in soft-gel capsules | Drug | CBD 200 mg OD |
| PlaceboSoft-gel capsules containing placebo | Drug | Placebo |
Primary outcome
The mean change in the number of headache days between the 4-week baseline period compared to the 4-week period just preceding the 3 month follow-up visit.
Time frame: Baseline and weeks 9-12
10 secondary outcomes
The mean change in the number of headache days between baseline compared to the 4-week period just preceding the 6 month follow-up visit.
Time frame: Weeks -4 to 0 and weeks 21-24
The percentage of patients who have at least a 50% reduction in their headache frequency between baseline compared to weeks 9-12 (the 50% responder rate).
Time frame: Weeks -4 to 0 and weeks 9-12
The change in the mean headache intensity between baseline compared to weeks 9-12, and weeks 21-24.
Time frame: Weeks -4 to 0, weeks 9-12 and weeks 21-24
The mean change in the number of days with acute pain medication use between baseline compared to weeks 9-12, and 21-24.
Time frame: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in Migraine Disability Assessment (MIDAS) Test score between baseline compared to weeks 9-12, and 21-24.
Time frame: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in Headache Impact Test (HIT-6) score between baseline compared to weeks 9-12, and 21-24.
Time frame: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in Generalized Anxiety Disorder (GAD-7) score between baseline compared to weeks 9-12, and 21-24.
Time frame: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in Patient Health Questionnaire (PHQ-9) score between baseline compared to weeks 9-12, and 21-24.
Time frame: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in Migraine Specific Quality of Life Questionnaire (MSQ) score between baseline compared to weeks 9-12, and 21-24.
Time frame: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Change in the Pittsburgh Sleep Quality Index (PSQI) score between baseline compared to weeks 9-12, and 21-24.
Time frame: Weeks -4 to 0, weeks 9-12 and weeks 21-24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
CHAMP Research (Calgary Headache Assessment & Management Prog) contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CBD 100 mg OD and CBD 200 mg OD in people with Chronic Migraine, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHAMP Research (Calgary Headache Assessment & Management Prog) (403-956-3427 or 403-956-3548, champ.research@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean change in the number of headache days between the 4-week baseline period compared to the 4-week period just preceding the 3 month follow-up visit. (time frame: Baseline and weeks 9-12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.