Title: Prospective study of a formulation with cannabis oil in pediatric epilepsy resistant to treatment

Biography:

Latin American Cannabinoid Study Group in Epilepsy 
City of Panama, Republic of Panama

Abstract

In this prospective and open design study, a cannabis formulation with predominant CBD content and very low THC content will be evaluated to treat pediatric treatment-resistant epilepsy (TRE) in Panama. We plan to include in a simple random way twenty participants in this study between the ages of 0-18 years (TRE). Patients with prior pharmacological reaction to cannabinoids, family history of schizophrenia, sensitivity to cannabinoids or heart, liver or kidney disease, and congenital metabolic will be excluded.

Patients will be subject to a 4-week pre-intervention period in which a diary of seizures and quality of life will be completed. A 24-hour ambulatory electro-encephalogram (EEG), blood levels of antiepileptic drugs, and liver tests will be obtained, both at the beginning and at the end of the study.

Upon completion of the observation period, patients will receive an oral pharmaceutical grade formulation containing predominantly purified CBD and a minimum ratio of THC oil, in a 50: 1 ratio, maintaining a dose of THC at least 0.5 mg / kg / day, with an initial dose of 2 mg / kg / day of CBD and 0.04 mg / kg / day of THC, divided twice a day and the dose will be determined and adjusted until optimal levels are achieved for the patient. The treatment period will 5 take months.

Our main outcome will be the absence of seizures. Our secondary outcome measure will be the frequency of seizures, quality of life and the side effects associated with the cannabinoid formulation. Such measures will be determined after every month of treatment, as well as the safety and tolerability of the treatment. Secondary measures will be evaluated by completing a questionnaire on the quality of life by the guardian. An outpatient EEG will also be performed after the 1st month of treatment, the 3^rd month and at the end of the study.

Also, these reviews will be repeated for neurological examination monthly. A univariate analysis will be performed using measures of central tendency, dispersion, means and medians according to the trend of the data. For the analysis of the effect of the formulation dose on the incidence of seizures, we plan to use non-parametric tests. For the comparison of the results before and after the intervention, we plan to use paired tests.