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

  • STATUS
    Recruiting
  • End date
    Jan 15, 2027
  • participants needed
    40
  • sponsor
    Xenon Pharmaceuticals Inc.
Updated on 15 September 2022
ezogabine

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).

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.

Details
Condition Epilepsy, Epilepsy in Children, Epilepsy; Seizure, Disease, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Epileptic Syndromes
Treatment Placebo, XEN496
Clinical Study IdentifierNCT04912856
SponsorXenon Pharmaceuticals Inc.
Last Modified on15 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject completed participation in the primary study, XPF-009-301. A subject who withdraws from the primary study due to meeting protocol-specified worsening criteria will be considered as having completed participation in the primary study
The caregiver is willing and able to be compliant with diary completion, visit schedule, and study drug administration
Subject's caregiver achieved a minimum of 85% compliance with daily diary completion during both baseline and the double-blind period of the primary study

Exclusion Criteria

Any adverse event(s) or serious adverse event(s) during the primary study XPF-009-301, which in the opinion of the investigator and sponsor's medical monitor, would preclude the subject's entry into the OLE study
A clinically significant condition or illness, or symptoms other than those resulting from KCNQ2-DEE, present at screening/baseline that, in the opinion of the investigator, would pose a risk to the subject if s/he were to enter the study
Any conditions that were specified as exclusion criteria in the primary study, XPF-009-301
It is anticipated that the subject will require treatment with at least 1 of the disallowed medications during the study
Any change in cardiac rhythm or atrioventricular conduction in the primary study that, in the investigator's opinion, is a significant risk to subject safety
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