Long-term study of XEN1101 for epilepsy with seizures
Tests XEN1101 long term in people aged 12 or older with epilepsy.
Plain-language title generated from the registry record
Registry title: An Open-label Study of XEN1101 in Epilepsy
Key facts
- Where
- Aachen, Berlin, Bielefeld, Bonn, Frankfurt, Freiburg im Breisgau, Marburg, Munich, Radeberg, Tuebingen, and Ulm, GermanySee the 11 sites
- Phase
- Phase 3
Where in Germany
- Universitaetsklinikum Aachen AöRAachen, GermanyTaking people
- Vivantes Netzwerk fuer Gesundheit GmbHBerlin, GermanyTaking people
- Gesellschaft Fuer EpilepsieforschungBielefeld, GermanyTaking people
- Rheinische Friedrich-Wilhelms-Universitaet BonnBonn, GermanyTaking people
- Universitätsklinikum FrankfurtFrankfurt, GermanyTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
- Philipps-Universitaet MarburgMarburg, GermanyTaking people
- Klinikum der Universitaet Muenchen AöRMunich, GermanyTaking people
- Epilepsiezentrum Kleinwachau gGmbHRadeberg, GermanyTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking people
- Universitaetsklinikum Ulm AoRUlm, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xenon Pharmaceuticals Inc.
- Trial code
- NCT05718817EU 2022-502282-24-00
- Record updated
- 2 November 2026
- Original description
This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.Read full original descriptionShow less
A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy
This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.
Inclusion: Subject must be properly informed of the nature and risks of the study and give informed consent in writing prior to entering the study (for adult subjects) and for adolescent subject's parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study; Subject must have successfully completed the double-blind treatment period (DBP) and have not terminated early from Study X-TOLE2, X-TOLE3, or X-ACKT, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or adverse events (AEs) (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study; In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements; Subject is able to keep accurate seizure diaries.
Exclusion: Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy or any other medical condition during the study and until 28 days after completion of this study; Subject has any medical condition, personal circumstance, or ongoing AE (from Study X-TOLE2, X-TOLE3, or X-ACKT) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol; Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT.