Cannabis for the Prophylactic Treatment of Migraine

NCT03972124 | Recruiting Phase 2 DMC

• 1 other identifier: REB19-0889
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Migraine

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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).

  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.

  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.

  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.

  Weeks -4 to 0, weeks 9-12 and weeks 21-24

Study Arms (3)

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.

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.

Drug: CBD 200 mg OD

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CBD 100 mg OD DRUG

CBD oil - purified to \<1% THC in soft-gel capsules

CBD 100 mg OD

CBD 200 mg OD DRUG

CBD oil - purified to \<1% THC in soft-gel capsules

CBD 200 mg OD

Placebo DRUG

Soft-gel capsules containing placebo

Placebo

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

CHAMP Research (Calgary Headache Assessment & Management Program)

Calgary, Alberta, T3M 1M4, Canada

RECRUITING

Central Study Contacts

CHAMP Research (Calgary Headache Assessment & Management Prog)

CONTACT

403-956-3427 or 403-956-3548; champ.research@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRCPC. Clinical Associate Professor

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 3, 2019
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)