A Randomized Study of XEN1101 Versus Placebo in Primary Generalized Tonic-Clonic Seizures (X-ACKT)
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 Primary Generalized Tonic-Clonic Seizures
IRAS ID
1007246
Contact name
Ariel Le Huquet
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 generalized epilepsy and experiencing probable or possible PGTCS.
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 PGTCS frequency in subjects with PGTCS 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 29.5 weeks broken down into 3 time periods – Screening/Baseline Period, Double-blind Treatment Period, and Post-Treatment Follow Up Period. Once they complete the Double-blind Treatment Period, participants may be eligible to participate in the Open-label Extension XPF-010-303 (OLE) Study still to be submitted.
At the beginning of the Double-blind Treatment Period, participants will be randomised to 1 of 2 treatment groups: 1 group will receive XEN1101 at a daily dose of 25 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 the participants are 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 of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0082
Date of REC Opinion
1 Sep 2023
REC opinion
Further Information Favourable Opinion