An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE — EPIK-OLE  

Epilepsy Clinical Trial

Official title: An Open-Label Extension of the Study XEN496 in Children With KCNQ2 Developmental and Epileptic Encephalopathy

Status Terminated

Clinical Trial Summary

To assess the long-term safety and tolerability of XEN496 in pediatric subjects with KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE) who had participated in the primary study (XPF-009-301).

Clinical Trial Description

This is an open-label, long-term extension study of XEN496 for the treatment of seizures in subjects with KCNQ2-DEE, that will be open to eligible subjects who participated in the primary study, XPF-009-301. The primary objective is to assess the long-term safety of XEN496. A double-blind transition/titration period will be used to maintain blinding to the treatment allocation in the primary study (XPF-009-301). After completion of the blinded transition/titration period, subjects will receive the open label study drug at their optimal dose for approximately 35 months. ;

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: NCT04912856
• Study type: Interventional
• Source: Xenon Pharmaceuticals Inc.
• Status: Terminated
• Phase: Phase 3
• Start date: August 17, 2021
• Completion date: November 17, 2023