Last updated 23 months ago
Cannabidiol 133mg + Cannabigerol 66mg + Tetrahydrocannabinol 4mg vs Placebo as Adjuvant Treatment in Chronic Migraine -
110 patients around the world
Available in Brazil
Hospital Israelita Albert Einstein
1Research sites
110Patients around the world
This study is for people with
Migraine
Requirements for the patient
To 65 Years
All Gender
Medical requirements
- Patients of both sexes, 25 to 65 years old, with chronic migraine according to IHS Classification System, 3rd editionUndergoing preventive treatment in a stable dose of the preventive medication for at least 2 months, who have not used cannabidiol to treat migraine.At least 5 days of migraine/migraine like attacks in the baseline period (4 weeks)As preventive drugs propranolol, atenolol, topiramate, valproic acid/sodium valproate, levetiracetam, gabapentin, lamotrigine, pre-gabaline, flunarizine, amitriptyline, nortriptyline, clomipramine, candesartan, galcanezumab, erenumab, fremanezumab, botulinum toxin type A will be allowed. Patients whose preventive treatment for migraine is Botulinum Toxin Type A may participate in the study as long as the toxin application interval used is 4 months (duration of medication or placebo use) and who have already received treatment with toxin at least 2 times.If acute treatment is necessary, patients may use the medications as previously advised by the physician accompanying them, and may use common, combined painkillers, anti-inflammatory drugs, triptans, triptans combined with anti-inflammatory drugs, opioid analgesics.
- Patients with active liver diseasepregnancy and/or women who intend to become pregnant or who do not make adequate use of contraceptive therapy/methodsbreastfeeding womenuse of cannabis during the study, whether with therapeutic or recreational intentionspatients who are without preventive treatment or who have undergone a dose change in preventive migraine treatment less than two months before V1 .Patients whose exclusive treatment for chronic migraine is Botulinum Toxin Type A at intervals of less than 4 months.History of substance abuse or addiction, use of medical cannabis or products with CBD, CBG or THC in the last 30 days, history of allergy to CBD or related productselevated transaminases > 3x the normal valuesubstance abuserspatients using substances that are potent enzyme inducers, such as rifampicin, ketoconazole, theophylline, carbamazepine, phenytoin, phenobarbital and St. John's wort, clobazam, macrolides, verapamil, fluoxetine, amiodarone and tacrolimus.Patients using anticoagulant, like vitamin K anticoagulant medicines, as warfarin.
Sites
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Recruiting
StudyCAMTREA
SponsorHospital Israelita Albert Einstein
Study typeInterventional
Conditions
Requirements
To 65 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04989413
