Evaluate Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures, X-TOLE2
IRAS ID
1006896
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 of seizures. XEN1101 is a study medication because its safety, effectiveness, and/or how it works is still being studied. 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 patients 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 compare XEN1101 to a placebo to see if XEN1101 is safe and works better than the placebo.
The study will last for about 7 months per protocol, with follow-up of 8 weeks, now broken down into 3 time periods – Screening/Baseline Period, Double-blind Treatment Period, and Post-Treatment Follow‑Up Period. Once complete the Double-blind Treatment Period, participants may be eligible to participate in a separate Open-label Extension (OLE) Study- protocol number X-TOLE 4, still to be submitted.
At the beginning of the Double-blind Treatment Period, participants will be randomised to 1 of 3 treatment groups: 1 group will receive XEN1101 at a daily dose of 25 mg, 1 group will receive XEN1101 at a daily dose of 15 mg, and 1 group will receive placebo.
Once participants have completed the Double-blind Treatment Period, they may be eligible for a separate OLE Study, and they will be asked to sign a new PIS if they want to participate. During the OLE Study, everyone will get XEN1101 and there is no placebo. If they were receiving placebo during the Double-blind Treatment Period, they will be switched to XEN1101 when they enter the OLE Study. The participants and the study team will know that the participant is getting XEN1101 and the dose that has been prescribed.REC name
East Midlands - Derby Research Ethics Committee
REC reference
23/EM/0010
Date of REC Opinion
17 Aug 2023
REC opinion
Further Information Favourable Opinion