An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE (NCT04912856) | Clinical Trial Compass
TerminatedPhase 3
An Open-Label Extension of the Study XEN496 (Ezogabine) in Children With KCNQ2-DEE
Stopped: Sponsor decision; not a safety decision
United States, Australia, Belgium8 participantsStarted 2021-08-17
Plain-language 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).
Who can participate
Age range1 Month – 6 Years
SexALL
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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.
What they're measuring
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Intervention
Timeframe: From Screening/Baseline through to 4 weeks post last dose