Status:
TERMINATED
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE
Lead Sponsor:
Xenon Pharmaceuticals Inc.
Conditions:
Epilepsy
Epilepsy in Children
Eligibility:
All Genders
1-6 years
Phase:
PHASE3
Brief 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-0...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04912856
Start Date
August 17 2021
End Date
November 17 2023
Last Update
February 14 2025
Active Locations (4)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
2
MultiCare Health System - Mary Bridge Pediatrics - Tacoma
Tacoma, Washington, United States, 98405
3
Sydney Children's Hospital
Sydney, New South Wales, Australia, 2031
4
Universitair Ziekenhuis Antwerpen - Dienst Kinderneurologie
Edegem, Antwerpen, Belgium, 2650