Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hospital Israelita Albert Einstein
With
Industria Farmacêutica Health Meds
Age
25–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients of both sexes, 25 to 65 years old, with chronic migraine according to IHS Classification System, 3rd edition
Undergoing 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.
You may not be if
Patients with active liver disease
pregnancy and/or women who intend to become pregnant or who do not make adequate use of contraceptive therapy/methods
breastfeeding women
use of cannabis during the study, whether with therapeutic or recreational intentions
patients 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 products
elevated transaminases \> 3x the normal value
substance abusers
patients 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.
Clareo Health | Cannabidiol 133mg + Cannabigerol 66mg + Tetrahydrocannabinol 4mg Vs Placebo As Adjuvant Treatment in Chronic Migraine -
