Cannabis for the Prophylactic Treatment of Migraine

NCT ID: NCT03972124

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

CBD 100 mg OD

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.

Group Type: ACTIVE_COMPARATOR

CBD 100 mg OD

Intervention Type: DRUG

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

CBD 200 mg OD

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.

Group Type: EXPERIMENTAL

CBD 200 mg OD

Intervention Type: DRUG

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

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Soft-gel capsules containing placebo

Interventions

CBD 100 mg OD

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

Intervention Type: DRUG

CBD 200 mg OD

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

Intervention Type: DRUG

Placebo

Soft-gel capsules containing placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: lead

Responsible Party

Farnaz Amoozegar

MD, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

REB19-0889

Identifier Type: -

Identifier Source: org_study_id