To investigate the potential antiseizure effects of adjunctive XEN496 (ezogabine) compared
with placebo in children with KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE).
The EPIK Phase 3 clinical trial is designed as a randomized, double-blind,
placebo-controlled, multicenter study targeting to enroll approximately 40 pediatric subjects
(aged from 1 month to less than 6 years) with documented genetic evidence consistent with a
diagnosis of KCNQ2 Developmental and Epileptic Encephalopathy (KCNQ2-DEE). After screening,
subjects will enter a baseline period before being randomized to receive either XEN496
(ezogabine) or placebo, added to their existing antiseizure medications (ASMs), for 12 weeks
(maintenance), once a titration period of up to 24 days is complete. At the end of the
maintenance phase, eligible subjects will have the opportunity to qualify for and participate
in the separate open-label extension (OLE) study and receive XEN496 or, should they choose to
exit the study, will undergo a dose taper period of up to 15 days and 4-week follow-up.
Epilepsy, Epilepsy in Children, Epilepsy; Seizure, Disease, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Epileptic Syndromes
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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