A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
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, Placebo.
- Who it may be relevant to
- Registry conditions: Focal Onset Seizures. Basic parameters: from 18 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 +15
- 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 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
Overview
The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.
Detailed description
Approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (XEN1101 25 mg : 15 mg : Placebo). Eligible subjects will have up to 9.5 weeks of baseline to assess frequency of seizures, followed by 12 weeks of blinded treatment. In order to be included in the study, subjects must be treated with a stable dose of 1 to 3 allowable antiseizure medications (ASMs) for at least one month prior to screening, during baseline, and throughout the double-blind treatment period (DBP) of the study. During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal.
Subjects who complete the 12-week DBP will have the opportunity to qualify and enroll in a separate open-label extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter a 8-week post treatment follow-up period.
Interventions
- Drug XEN1101
XEN1101 Capsules - Drug Placebo
Placebo Capsules
Primary outcome measures
- Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo. [Time frame: From baseline through to the double blind period (week 12).]
Secondary outcome measures (4)
- Proportion of subjects experiencing ≥50% reduction in focal seizure frequency from baseline through the DBP for XEN1101 versus placebo. [Time frame: From baseline through to the double blind period (week 12).]
- MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo. [Time frame: From baseline through to the week 1.]
- Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C). [Time frame: From baseline through to the double blind period (week 12).]
- To assess adverse events as criteria for safety and tolerability of XEN1101. [Time frame: From screening through to 56 days post-final dose]
Eligibility criteria
Inclusion criteria
- Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
- Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.
- Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP
- Able to keep accurate seizure diaries
Exclusion criteria
- Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
- History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
- Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.
- History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
- History of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to enrollment.
- Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 19 centers
- Clinical Trials, Inc. — Little Rock
- Rancho Research Institute — Downey
- University of California Los Angeles (UCLA) — Los Angeles
- University of California Irvine Health — Orange
- Panhandle Research and Medical Clinic — Gulf Breeze
- Mayo Clinic Florida — Jacksonville
- Consultants in Epilepsy and Neurology, PLLC — Boise
- Southern Illinois University School of Medicine — Springfield
- … and 11 more centers
Argentina · 12 centers
- Hospital Ramos Mejia — Buenos Aires
- Hospital De Alta Complejidad en Red el Cruce — Buenos Aires
- Policlinico Lomas — Buenos Aires
- Instituto de Neurologia Cognitiva (INECO) — Buenos Aires
- Hospital Italiano — Buenos Aires
- Hospital Britanico de Buenos Aires — Buenos Aires
- STAT Resarch S.A. — Buenos Aires
- CENyR Centro de Especialidades Neurologicas y Rehabilitacion — C.a.b.a.
- … and 4 more centers
Portugal · 8 centers
Center list to be confirmed — check the primary protocol.
Australia · 6 centers
- Royal Prince Alfred Hospital — Camperdown
- Prince of Wales Hospital — Randwick
- Westmead Hospital — Westmead
- Alfred Hospital — Melbourne
- Austin Health — Melbourne
- Royal Melbourne Hospital — Melbourne
France · 6 centers
- Hopital Neurologique Pierre Wertheimer — Bron
- Centre Hospitalier Universitaire de Lille (CHU de Lille) — Lille
- Hôpital de la Pitié Salpêtrière — Paris
- Hôpital Fondation A. de Rothschild — Paris
- Chu de Rennes Hôpital Pontchaillou — Rennes
- Hôpital de Hautepierre — Strasbourg
Croatia · 5 centers
- University Hospital Center Osijek — Osijek
- Clinical Hospital Center Rijeka, Klinika za Neurologiju — Rijeka
- Poliklinika Bonifarm — Zagreb
- University Hospital Center Zagreb — Zagreb
- Poliklinika LF MEDICAL — Zagreb
Poland · 5 centers
- COPERNICUS Podmiot Leczniczy — Gdansk
- NZOZ Neuromed M. i M. Nastaj Sp. P. — Lublin
- … and 3 more centers
Chile · 4 centers
- Clinica Universidad de Los Andes — Santiago
- Centro de Investigacion Clinica UC — Santiago
- CINSAN — Santiago
- Hospital Clínico Viña del Mar — Viña del Mar
Israel · 4 centers
- Hadassah Medical Center — Jerusalem
- The Chaim Sheba Medical Center — Ramat Gan
- Kaplan Medical Center — Rehovot
- The Tel Aviv Sourasky Medical Center — Tel Aviv
Mexico · 4 centers
- Grupo Medico Camino — Benito Juárez
- Human Science Research Trials — Mexico City
- Axis Heilsa S. de R.L. de C.V. Althian — Monterrey
- Neurocencias Esudios Clinicos S.C. — Sinaloa
Spain · 4 centers
Center list to be confirmed — check the primary protocol.
Austria · 3 centers
- University Hospital Innsbruck — Innsbruck
- Universitätsklinik für Neurologie — Salzburg
- Medical University of Vienna — Vienna
Czechia · 3 centers
- EUC Hradec Kralove Clinic — Hradec Králové
- Nemocnicni lekarna FN Motol / Motol University Hospital — Prague
- Forbeli s.r.o. — Prague
Germany · 3 centers
- Universitätsklinikum Aachen — Aachen
- Krankenhaus Mara gGmbH — Bielefeld
- University Hospital Frankfurt, ZNN - Epilepsy Center Frankfurt Rhine-Main — Frankfurt
Belgium · 2 centers
- Cliniques Universitaires Saint-Luc (UCL) — Brussels
- Universitair Ziekenhuis Gent — Ghent
Bulgaria · 2 centers
- MHATNPsy Sveti Naum EAD — Sofia
- Medical center OPHTHA-NEURO — Sofia
Italy · 2 centers
- Ospedali Riuniti di Ancona — Ancona
- Università degli studi di Bari Aldo Moro — Bari
Finland · 1 center
- Kuopio University Hospital — Kuopio
Hungary · 1 center
- Semmelweis Egyetem, Idegsebészeti és Neurointervenciós Klinika — Budapest
Netherlands · 1 center
- Kempenhaeghe — Heeze
Identifiers
NCT: NCT05716100 · XPF-010-302 · 2022-502281-25-00