NCT05324449

Epidiolex® for Anxiety in Pediatric Epilepsy

Epidiolex® For The Treatment Of Anxiety Comorbidity in Refractory Pediatric Epilepsy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. · Academic / Other
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective open label study assessing the efficacy and tolerability of pharmaceutical grade cannabidiol--Epidiolex (R), for the treatment of anxiety in pediatric patients with pediatric epilepsy that has been difficult to treat and requires ongoing use of anticonvulsant medication.

Detailed description

This study is an open label, adjunctive, proof of concept clinical trial. Prospective participants will be considered for the study if neurologic status suggests the need for continued treatment, and behavioral characteristics are clinically significant. All participants will receive active treatment, involving flexible dose titration of Epidiolex® and will be monitored for a period of four months. The study will be monitored and overseen by the Johns Hopkins Hospital Institutional Review Board.

Conditions

• Anxiety
• Epilepsy

Interventions

Type	Name	Description
DRUG	Cannabidiol 100 MG/ML	pharmaceutical grade cannabidiol

Timeline

• Start date: 2022-04-05
• Primary completion: 2025-03-17
• Completion: 2025-05-05
• First posted: 2022-04-12
• Last updated: 2025-07-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study