An Open-label Study of XEN1101 in Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: XEN1101.
- Who it may be relevant to
- Registry conditions: Focal Epilepsy, Tonic-Clonic Seizures. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +19
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy
Overview
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.
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 in subjects with FOS or PGTCS for the treatment of seizures for up to 6 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 6 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.
Subjects will be initially assigned to XEN1101 as follows:
* 25 mg QD for subjects aged ≥18 years * For subjects aged ≥12 and \<18 years
* 15 mg QD for those
* who weigh \<45 kg at the start of the X-TOLE4 study * who weighed \<45 kg during the X-ACKT study * who weighed ≥45 kg at randomization in the X-ACKT study and had dose reduction(s) for intolerability * 25 mg QD for all others
Subjects will be instructed to orally take XEN1101 once daily (QD) 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.
Interventions
- Drug XEN1101
XEN1101 capsules
Primary outcome measures
- The adverse events [Time frame: From the start of treatment in the open-label extension (OLE) study through 8 weeks after the last dose.]
Secondary outcome measures (5)
- Change in monthly seizure rate [Time frame: From baseline through the active extension treatment (Week 312).]
- Proportion of responders [Time frame: From baseline through the active extension treatment (Week 312).]
- Change in Clinical Global Impression of Severity (CGI-S) [Time frame: From baseline through the active extension treatment (Week 312).]
- Change in Patient Global Impression of Severity (PGI-S) [Time frame: From baseline through the active extension treatment (Week 312).]
- Change in Quality of Life in Epilepsy Inventory (QOLIE-31) [Time frame: From baseline through the active extension treatment (Week 312).]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT.
- 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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 54 centers
- Xenoscience — Phoenix
- University of Arizona - Health Sciences — Tucson
- Clinical Trials, Inc — Little Rock
- Brain Science Research Institute — Los Angeles
- UC Irvine Health — Orange
- University of California, Davis Clinical & Translational Science Center Clinical Research — Sacramento
- University of Colorado Hospital Anschutz Outpatient Pavilion — Aurora
- Mayo Clinic Florida — Jacksonville
- … and 46 more centers
Argentina · 12 centers
- Hospital General de Agudos "José M. Ramos Mejía" — Buenos Aires
- Asociacion Medica de Lomas de Zamora S.A. - Policlinicio Lomas — Buenos Aires
- STAT Research S.A. — Buenos Aires
- Centro de Psicología Médica San Martín de Tours SRL (CITES-INECO) — Buenos Aires
- Hospital Italiano de Buenos Aires — Buenos Aires
- Hospital Britanico de Buenos Aires — Buenos Aires
- CENyR, Centro de Especialidades Neurologicas u Rehabilitacion — Buenos Aires
- FLENI (Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia) — Buenos Aires
- … and 4 more centers
Spain · 10 centers
Center list to be confirmed — check the primary protocol.
Australia · 9 centers
- Prince of Wales Hospital — Randwick
- Royal Prince Alfred Hospital — Camperdown
- St Vincent's Hospital Melbourne — Fitzroy
- Austin Health Pharmacy Clinical Trials — Heidelberg
- Southern Neurology — Kogarah
- Alfred Hospital Neurology CT Dept of Neuroscience — Melbourne
- The Royal Melbourne Hospital — Parkville
- Mater Misericordiae Ltd South Brisbane — South Brisbane
- … and 1 more center
Germany · 7 centers
Center list to be confirmed — check the primary protocol.
Portugal · 7 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 7 centers
Center list to be confirmed — check the primary protocol.
Poland · 6 centers
Center list to be confirmed — check the primary protocol.
France · 5 centers
Center list to be confirmed — check the primary protocol.
Italy · 4 centers
Center list to be confirmed — check the primary protocol.
Mexico · 4 centers
Center list to be confirmed — check the primary protocol.
Canada · 3 centers
Center list to be confirmed — check the primary protocol.
Croatia · 3 centers
Center list to be confirmed — check the primary protocol.
Israel · 3 centers
Center list to be confirmed — check the primary protocol.
Austria · 2 centers
- University Hospital Innsbruck — Innsbruck
- Universitatsklinik fur Neurologie, Medizinische Universitat Wien — Vienna
Belgium · 2 centers
- Cliniques Universitaires Saint-Luc (UCL) — Brussels
- Universitair Ziekenhuis Gent — Ghent
Bulgaria · 2 centers
- Hospital for active treatmnt Puls AD Neurology Dpt — Blagoevgrad
- … and 1 more center
Chile · 2 centers
Center list to be confirmed — check the primary protocol.
Czechia · 2 centers
Center list to be confirmed — check the primary protocol.
Georgia · 2 centers
Center list to be confirmed — check the primary protocol.
New Zealand · 2 centers
Center list to be confirmed — check the primary protocol.
Finland · 1 center
Center list to be confirmed — check the primary protocol.
Hungary · 1 center
Center list to be confirmed — check the primary protocol.
Ireland · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05718817 · XPF-010-304 · 2022-502282-24-00