Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05718817
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-05
First Post:
2023-01-13
Brief Title:
An Open-label Study of XEN1101 in Epilepsy
Sponsor:
Xenon Pharmaceuticals Inc
Organization:
Xenon Pharmaceuticals Inc
Study Overview
Official Title:
A Multicenter Open-label Long-term Safety Tolerability and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
X-TOLE4
Brief Summary:
This study will evaluate the long term safety tolerability PK and efficacy of XEN1101 25 mg QD taken orally in subjects with Focal Onset Seizures FOS or Primary Generalized Tonic-Clonic Seizures PGTCS for the treatment of seizures for up to 3 years
Detailed Description:
This is an Open Label Extension study of the following Phase 3 clinical studies XPF-010-301 X-TOLE2 XPF-010-302 X-TOLE3 and XPF-010-303 X-ACKT This study will evaluate the long term safety tolerability PK and efficacy of XEN1101 25 mg QD taken orally once daily QD in subjects with FOS or PGTCS for the treatment of seizures for up to 3 years Subjects who successfully completed and did not terminate early from one of the antecedent studies X-TOLE2 X-TOLE3 or X-ACKT are eligible to participate in X-TOLE4
Following enrollment into X-TOLE4 subjects will undergo a treatment period of up to 3 years during which there will be a visit at 2- 4- and 13-weeks post-entry with subsequent visits occurring at 13 week intervals during the first year and then at 26-week intervals with a telephone call in between until dosing is completed All subjects will be initially assigned to receive 25 mg QD of XEN1101 Subjects will be instructed to orally take XEN1101 once daily with an evening meal Subjects will be expected to keep a daily seizure eDiary with a minimum of 80 compliance for the duration of the extension study reporting on 80 of days between visits
Upon completion of dosing at the end of the treatment period there will be an 8-week follow up period
Following enrollment into X-TOLE4 subjects will undergo a treatment period of up to 3 years during which there will be a visit at 2- 4- and 13-weeks post-entry with subsequent visits occurring at 13 week intervals during the first year and then at 26-week intervals with a telephone call in between until dosing is completed All subjects will be initially assigned to receive 25 mg QD of XEN1101 Subjects will be instructed to orally take XEN1101 once daily with an evening meal Subjects will be expected to keep a daily seizure eDiary with a minimum of 80 compliance for the duration of the extension study reporting on 80 of days between visits
Upon completion of dosing at the end of the treatment period there will be an 8-week follow up period
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