NCT04912856

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Xenon Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 1 Month – 6 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	XEN496	XEN496 sprinkle capsules. Parents / caregivers will be instructed to sprinkle and mix the contents of the capsules into soft foods or liquids and feed it to the child.

Timeline

• Start date: 2021-08-17
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2021-06-03
• Last updated: 2025-02-14
• Results posted: 2025-02-14

Locations

4 sites across 3 countries: United States, Australia, Belgium

Regulatory

• FDA-regulated drug study