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New treatment option for Chronic Migraine
Official title Cannabis for the Prophylactic Treatment of Migraine
ClinicalTrials.gov ID: NCT03972124
What this study is testing
What is CBD 100 mg OD?
CBD 100 mg OD is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic migraine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 and older
You may be able to join 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...
You likely can't join 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.
See the full eligibility 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...
- 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 how well it works with an appropriate trial of the medication, or due to lack of side effects.
- 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.
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.