cannabis extract in refractory epilepsy study

Conditions: Drug Resistant Epilepsy

Summary: the purpose of this study is to examine whether a low dose of cbd+thc will decrease the frequency of convulsive seizures in adults with drug-resistant epilepsy, when used in addition to standard anti-epileptic drugs (aeds). this study will also study the genes associated with epilepsy and whether different epileptic syndromes respond to treatment with cbd+thc.

background: cannabidiol (cbd) and δ9-tetrahydrocannabinol (thc) are the two major compounds found in the cannabis plant. reports from patients, families, and the scientific community suggest that cbd (when used as an add-on therapy) decreases the number of convulsive seizures in children and adults with dravet syndrome, lennox-gastaut syndrome, and tuberous sclerosis complex. trial design: phase iii, double-blind, randomized, placebo-controlled, parallel-group trial, followed by an open phase where treatment allocation will be revealed and all participants will either continue or begin receiving the active study drug. participants: adults (18 years of age and older) with drug-resistant epilepsy, including patients with dravet and lennox gastaut syndromes, and patients with frequent convulsive seizures (e.g., tonic, tonic-clonic, atonic, drop attacks, and focal motor seizures). interventions: capsules containing a ratio of 16 cbd: 1 thc oil at a maximum total daily dose of approximately 300 mg of cbd per day, divided into equal doses in the morning and evening. comparator: placebo capsules containing high-oleic sunflower oil and no active or medicinal ingredients. outcomes: frequency of seizures; side effects; blood levels of aeds, cbd, thc, and liver enzymes; impact on cognition and quality of life; genetics. sample size: a total of 80 participants (40 assigned to treatment and 40 to control group) recruited from toronto western hospital in toronto, and university hospital in london, ontario. time: each participant will be enrolled for approximately 16 to 18 weeks, while the clinical trial is expected to take place over a period of two years.

Eligibility criteria:
inclusion criteria: * diagnosis of epilepsy according to the ilae classification. * at least 4 motor seizures per month at the start of the study, despite treatment with at least two different anti-epileptic drugs (given concurrently or sequentially) for at least one year. * at least 4 motor seizures per month during the prospective baseline phase (4 weeks) with no 21-day seizure free periods. * stable dose(s) of the same aed(s) for one month prior to screening. * agrees not to take any cannabinoids during the study or any other investigational compound for one month before the study or outside cannabinoids during the study. * is planning to stay in canada for the duration of the trial. * is able to travel to one of the study sites for in-person visits with the study physicians and to a local lab for blood collection. * has access to telephone, computer, and internet for regular correspondence and to complete the study questionnaires. exclusion criteria: * participation in a study involving administration of an investigational compound within one month of visit 1. * evidence of clinically significant non-epileptic disease (cardiac, respiratory, gastrointestinal, hepatic, hematologic, or renal disease, etc.) that in the opinion of the investigators could affect the patient's safety or trial conduct. * progressive central nervous system (cns) disease, including degenerative cns diseases and progressive tumors. * occurrence of psychogenic seizures in the previous year. * history of drug misuse/abuse (other than cannabinoids). consideration may be given to allowing inclusion of subjects with remote history of drug abuse (within a defined relevant time period). * multiple drug allergies (dermatological, hematological, or organ toxicity) or more than one severe drug reaction(s). * pregnancy, breastfeeding. * known or suspected hypersensitivity to cannabinoids, or any of the excipients of the investigational medicinal product. * patients with a history of major depression, suicidal ideation or attempted suicide, schizophrenia or any other psychotic disorder, patients with a family history of schizophrenia.

Keywords: epilepsy drug resistant refractory seizures cannabidiol cbd cannabis