CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 89 enrolled
Drug / intervention
Epidiolexdrug
Likely dose
Epidiolex 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02695537
NCT02695537Phase 1Completed
CompareCT.gov

University of Alabama at Birmingham (UAB) Pediatric CBD Program

University of Alabama at Birmingham·interventional·Posted Mar 1, 2016·Updated Apr 10, 2020

In Brief

A Phase 1 clinical trial evaluating Epidiolex for Epilepsy and Seizures. Completed, enrolled 89 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Seizures
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 1, 2016
Enrollment StartApr 1, 2015
Primary CompletionFeb 27, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 10.3 years ago

Interventions

Epidiolexdrug

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