XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy — EPIK  

Epilepsy Clinical Trial

Official title: A Phase 3 Study of Adjunctive XEN496 in Pediatric Subjects With KCNQ2 Developmental and Epileptic Encephalopathy

Status Terminated

Clinical Trial Summary

To investigate the potential antiseizure effects of adjunctive XEN496 (ezogabine) compared with placebo in children with KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE).

Clinical Trial Description

The EPIK Phase 3 clinical trial is designed as a randomized, double-blind, placebo-controlled, multicenter study targeting to enroll approximately 40 pediatric subjects (aged from 1 month to less than 6 years) with documented genetic evidence consistent with a diagnosis of KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE). After screening, subjects will enter a baseline period before being randomized to receive either XEN496 (ezogabine) or placebo, added to their existing antiseizure medications (ASMs), for 12 weeks (maintenance), once a titration period of up to 24 days is complete. At the end of the maintenance phase, eligible subjects will have the opportunity to qualify for and participate in the separate open-label extension (OLE) study and receive XEN496 or, should they choose to exit the study, will undergo a dose taper period of up to 15 days and 4-week follow-up. ;

Related Conditions & MeSH terms

• Brain Diseases
• Central Nervous System Diseases
• Disease
• Epilepsy
• Epilepsy in Children
• Epilepsy; Seizure
• Epileptic Syndromes
• Nervous System Diseases
• Seizures

• NCT number: NCT04639310
• Study type: Interventional
• Source: Xenon Pharmaceuticals Inc.
• Status: Terminated
• Phase: Phase 3
• Start date: March 29, 2021
• Completion date: May 16, 2023