Ignite Creation Date:
2024-05-06 @ 4:13 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04912856
Status:
TERMINATED
Last Update Posted:
2023-12-26
First Post:
2021-05-03
Brief Title:
An Open-Label Extension of the Study XEN496 Ezogabine in Children With KCNQ2-DEE
Sponsor:
Xenon Pharmaceuticals Inc
Organization:
Xenon Pharmaceuticals Inc
Study Overview
Official Title:
An Open-Label Extension of the Study XEN496 in Children With KCNQ2 Developmental and Epileptic Encephalopathy
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision not a safety decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIK-OLE
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-009-301 The primary objective is to assess the long-term safety of XEN496 A double-blind transitiontitration period will be used to maintain blinding to the treatment allocation in the primary study XPF-009-301 After completion of the blinded transitiontitration period subjects will receive the open label study drug at their optimal dose for approximately 35 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-003447-28 | EUDRACT_NUMBER | None | None |