Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Xenon Pharmaceuticals Inc. (Voir sur ClinicalTrials)
mai 2023
décembre 2025
09 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Gilles HUBERFELD | 02/01/2025 09:55:32 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Lille (CHU de Lille) - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| Chu de Rennes Hôpital Pontchaillou - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Hôpital de Hautepierre - 67098 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hôpital de la Pitié Salpêtrière - 75013 - Paris - France | Contact (sur clinicalTrials) | ||||
| Hopital Neurologique Pierre Wertheimer - 69500 - Bron - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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.