An Open-label Study of XEN1101 in Epilepsy
Research type
Research Study
Full title
A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Adults Diagnosed With Epilepsy
IRAS ID
1007496
Contact name
Daniela Nenciu
Contact email
Sponsor organisation
Xenon Pharmaceuticals Inc
Clinicaltrials.gov Identifier
Research summary
In this research study a study medication named XEN1101 is being tested for the treatment in adult subjects diagnosed with epilepsy.
XEN1101 has not been approved for commercial use by government health authorities in any country, as a treatment for any
condition.
The main purpose of this study is to determine if XEN1101 can reduce the seizure frequency and if it is safe to use. XEN1101 has been tested in other studies in epilepsy participants and it was considered to be well-tolerated. It had side effects that are similar to other antiseizure medications commonly used to help patients with epilepsy.
The study will last for about 38 months (about 3 years) broken down into the following time periods: Enrollment, Treatment Period (156 weeks), and Post-Treatment Follow Up Period (8 weeks).
During the OLE Study, everyone will get XEN1101 and there is no placebo, the participants will receive XEN1101 at a daily dose of 25 mg QD of XEN1101.
This is an OLE 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 25 mg of XEN1101 taken orally 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.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0085
Date of REC Opinion
17 Aug 2023
REC opinion
Further Information Favourable Opinion