Cannabidiol 133mg + Cannabigerol 66mg + Tetrahydrocannabinol 4mg vs Placebo as Adjuvant Treatment in Chronic Migraine -

• Status: Not yet recruiting
• Trial end date: 2022-12-19

Summary

To evaluate the effect of the cannabidiol (CBD) + cannabigerol (CBG) + tetrahydrocannabinol (THC) up to 133/66/4mg daily versus placebo as adjuvant treatment in chronic migraine (CM) patients under preventive treatment at a stable dose for at least 3 months who present at least 5 headaches day a month. CM patients of both sexes, between 25 and 65 years old, who have not had CBD and/or THC as a migraine treatment. Patients may be having migraine preventive treatment such as propranolol, topiramate, valproic acid/sodium valproate, flunarizine, amitriptyline, nortriptyline, candesartan, galcanezumab, erenumab, fremanezumab, botulinum toxin type A. Acute treatment will follow patients doctor's prescription. Exclusion criteria: active liver disease or elevated liver transaminases> 3 times than the normal values, pregnancy, fertile age women without contraceptive treatment or who intend to get pregnant, patients without migraine preventive treatment, substance abuse or addiction, use of medical cannabis or products with CBD or THC in the last 30 days or during study period, history of allergy or adverse reactions with the use of CBD or related products, substance users of liver enzymes inducers such as rifampicin, ketoconazole, theophylline, carbamazepine, phenytoin, phenobarbital and St. John's wort. Patients on vitamin K anticoagulant medicines, as warfarin. After randomization patients will be divided into two groups of 55 participants, who will receive CBD + CBG + THC up to a maximum dose of 133/66/4 mg or placebo for 12 weeks (V0 screening, V1 allocation, V4 final visit).

The main outcome is the reduction in frequency of headache days per 4 weeks between V1 and V4 compared to placebo. Secondary outcomes will be a reduction in duration and intensity of migraine attacks, amount of painkillers used and percentage of patients with a reduction greater than 50% on migraine days, 50% reduction in the other variables as MIDAS scores, HIT-6 scores, Beck's Anxiety and Depression Scales, Epworth Sleepiness Scales, and the scores at The Severity of Dependence Scale used as an indicator of overuse medication in this sample.

The clinical and laboratory data obtained in this study will comply with the objectives elaborated in the evaluation of the primary and secondary, the proposal of which is to publish the data regardless of the results obtained.

• Phase: Phase 4

Details

• Lead Sponsor: Hospital Israelita Albert Einstein
• Collaborator: Industria Farmacêutica Health Meds
• Treatments: Cannabidiol; Dronabinol; Epidiolex