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Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating debilitating, drug-resistant epilepsy.


Clinical Trial Description

The specific goals of this phase 1 dose finding study, conducted in consecutively enrolled patients 18 years of age and older, are to prospectively and longitudinally assess the safety and tolerability, including cognitive effects, of Cannabidiol (CBD) at various doses between 5 mg/kg/day and 25 mg/kg/day, with additional titration in some cases up to 50 mg/kg/day. In order to participate in the study, participants will need to fulfill the inclusion and exclusion criteria.

The goal of the study is to fulfill the mandate of "Carly's Law" and to provide patients with debilitating epileptic conditions with access to CBD as an add-on treatment. Other care including routine neurological care unrelated to participation in the CBD study will need to be provided by patients' primary/current treating neurologist. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02700412
Study type Interventional
Source University of Alabama at Birmingham
Contact
Status Completed
Phase Phase 1
Start date April 2015
Completion date August 8, 2019

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