NCT02695537

University of Alabama at Birmingham (UAB) Pediatric CBD Program

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Year – 19 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Epilepsy
• Seizures

Interventions

Type	Name	Description
DRUG	Epidiolex	Epidiolex oral solution (100 mg/mL CBD concentration) with inactive ingredients including anhydrous ethanol, sesame seed oil, strawberry flavor, and sucralose).

Timeline

• Start date: 2015-04-01
• Primary completion: 2019-02-27
• Completion: 2019-02-27
• First posted: 2016-03-01
• Last updated: 2020-04-10
• Results posted: 2020-04-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study