University of Alabama at Birmingham (UAB) Pediatric CBD Program

Status Completed

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 I dose finding study, conducted in consecutively enrolled patients 1-19 years of age, 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

Clinical Trial Details

NCT number	NCT02695537
Study type	Interventional
Source	University of Alabama at Birmingham
Contact
Status	Completed
Phase	Phase 1
Start date	April 2015
Completion date	February 27, 2019

View Details

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