Tests XEN1101 against placebo for focal-onset seizures
Tests XEN1101 added to usual treatment in adults with focal-onset seizures.
Plain-language title generated from the registry record
Registry title: A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Key facts
- Where
- Buenos Aires, C.a.b.a., Córdoba, San Luis, and San Miguel de Tucumán, ArgentinaSee the 12 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who have had focal epilepsy for at least 2 years and still have seizures despite taking other seizure medicines.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Focal epilepsy diagnosed for at least 2 years, with seizures not fully controlled after at least 2 adequate seizure medicines (ASMs).
- Earlier treatment
- Must have tried at least 2 ASMs at adequate doses without lasting seizure freedom. Must be on a stable dose of 1 to 3 allowed ASMs for at least one month before screening.
Main reasons for not taking part
- Brain wave test (EEG) showing a pattern that does not fit focal seizures
- Only focal aware non-motor seizures, psychogenic non-epileptic seizures, primary generalized seizures, or developmental and epileptic encephalopathy such as Lennox-Gastaut syndrome
- Seizures caused by drug or alcohol use, infection, tumour, or progressive brain or nervous system disease
- Status epilepticus or repeated seizures in the past 12 months that cannot be counted individually
- Brain surgery for seizures less than 1 year ago, or radiosurgery less than 2 years ago
Read by machine on 9 November 2026.
Where in Argentina
- Hospital Britanico de Buenos AiresBuenos Aires, ArgentinaNo longer taking part
- Hospital De Alta Complejidad en Red el CruceBuenos Aires, ArgentinaNo longer taking part
- Hospital ItalianoBuenos Aires, ArgentinaNo longer taking part
- Hospital Ramos MejiaBuenos Aires, ArgentinaNo longer taking part
- Instituto de Neurologia Cognitiva (INECO)Buenos Aires, ArgentinaNo longer taking part
- Policlinico LomasBuenos Aires, ArgentinaNo longer taking part
- STAT Resarch S.A.Buenos Aires, ArgentinaNo longer taking part
- CENyR Centro de Especialidades Neurologicas y RehabilitacionC.a.b.a., ArgentinaNo longer taking part
- FLENIC.a.b.a., ArgentinaNo longer taking part
- Hospital CórdobaCórdoba, ArgentinaNo longer taking part
- Hospital Central Ramon CarriloSan Luis, ArgentinaNo longer taking part
- Sanatori del Sur S.A.San Miguel de Tucumán, ArgentinaNo longer taking part
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
- NCT05716100EU 2022-502281-25-00
- Record updated
- 2 November 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures; History of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to enrollment; 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; 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.