[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100360362":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":23,"centralContacts":36,"locations":42,"responsibleParty":59,"collaborators":23,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":23,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":23,"enrollmentInfo":72,"targetDuration":23,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":23,"overallStatus":45,"whyStopped":23,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"University of Calgary","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: CBD 100 mg OD",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Drug: CBD 200 mg OD",{"label":21,"type":22,"description":23,"interventionNames":24},"Placebo","PLACEBO_COMPARATOR",null,[25],"Drug: Placebo",[27,31,33],{"type":28,"name":9,"description":29,"armGroupLabels":30,"otherNames":23},"DRUG","CBD oil - purified to \\\u003C1% THC in soft-gel capsules",[9],{"type":28,"name":15,"description":29,"armGroupLabels":32,"otherNames":23},[15],{"type":28,"name":21,"description":34,"armGroupLabels":35,"otherNames":23},"Soft-gel capsules containing placebo",[21],[37],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},"CHAMP Research (Calgary Headache Assessment & Management Prog)","CONTACT","403-956-3427 or 403-956-3548","champ.research@ucalgary.ca",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"CHAMP Research (Calgary Headache Assessment & Management Program)","RECRUITING","Calgary","Alberta","T3M 1M4","Canada","CA",{"type":52,"coordinates":53},"Point",[54,55],-114.08529,51.05011,{"lat":55,"lon":54},[58],{"name":38,"role":39,"phone":40,"phoneExt":23,"email":41},{"type":60,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Farnaz Amoozegar","MD, MSc, FRCPC. Clinical Associate Professor","100360362","phase-2-cannabis-for-the-prophylactic-treatment-of-migraine-100360362",false,"NCT03972124","Cannabis for the Prophylactic Treatment of Migraine","Cannabis for the Prophylactic Treatment of Migraine: a Randomized Double-Blind Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n* Subject is willing and able to give signed informed consent.\n* Male and female patients aged 25 years or older.\n* History of migraine for at least 12 months as diagnosed by the International Classification of Headache Disorders (ICHD-3).\n* Chronic migraine for at least the previous 3 months prior to screening, as diagnosed by ICHD-3.\n* 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.\n* Using a reliable method of contraception for females of child-bearing age.\n* 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.\n* Able to follow study procedures, fill out headache diaries, and complete questionnaires.\n* Completion of at least 90% of the headache diary during the one month baseline period.\n\nExclusion Criteria:\n\n* Other active primary headaches, such as cluster headache, hemicrania continua, etc.\n* Any secondary headache, such as headache related to intracranial hypertension, intracranial hypotension, hydrocephalus, intracranial mass lesion, etc.\n* Pregnant, planning to become pregnant, or breastfeeding.\n* Active or significant history of major mental illness, including severe depression, or anxiety, and any history of psychosis or schizophrenia.\n* History of or current substance use disorder.\n* Regular use of cannabis for medical or recreational reasons during the previous 12 months.\n* History of significant cardiovascular or cerebrovascular disease, such as previous myocardial infarction, stroke, or peripheral vascular disease.\n* History of hypertension greater than 160\u002F100 and not medically treated.\n* Any past history of seizure disorder.\n* Liver disease or liver enzymes two or more times the upper limit of normal at baseline.\n* Severe renal disease or GFR more than 30% below expected.\n* Any disorder or condition leading to hypersomnolence or excessive daytime drowsiness, such as narcolepsy, excessive use of sedatives\u002Fhypnotics, etc.\n* 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.\n* 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).\n* 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).\n* Overuse of triptan, dihydroergotamine, opioid, or barbiturate medications, defined as 10 or more days per month in the 3 months prior to randomization.\n* 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.","ALL","25 Years",{"count":73,"type":74},72,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","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.",[80],"Chronic Migraine","2026-04-26",{"date":83,"type":84},"2026-05-01","ACTUAL",{"date":86,"type":84},"2026-04-01",{"date":88,"type":74},"2028-12",{"name":5,"class":6},1]