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 Primary Generalized Tonic-Clonic Seizures (X-ACKT)
Interventional
Phase 3
Xenon Pharmaceuticals Inc. (Voir sur ClinicalTrials)
février 2023
octobre 2025
30 avril 2025
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to
evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as
adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Lille, Hôpital Roger Salengro - Neurophysiologie clinique - 59037 - Lille - France | Contact (sur clinicalTrials) | ||||
| CHU de Rennes - Hôpital Pontchaillou - 35033 - Rennes - France | Contact (sur clinicalTrials) | ||||
| CHU de Strasbourg - Hôpital de Hautepierre - 67098 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Hopital Neurologique Pierre Wertheimer, Hospices Civils de Lyon - 9003 - Lyon - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Subject is properly informed of the nature and risks of the study and gives informed
consent in writing prior to entering the study (for adult subjects) and for
adolescent subjects parent/legal guardian and subject gives informed consent or
assent in writing prior to entering the study.
2. Subject is ≥12 years of age with a BMI ≤40 kg/m2 at Visit 1.
3. 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.
4. Subject has probable or possible PGTCS (with or without other subtypes of
generalized seizures) for ≥1 year, in the setting of generalized epilepsy according
to the International League Against Epilepsy 2017 classification criteria, and
subject is approved by The Epilepsy Study Consortium (TESC).
5. Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 1 month
prior to screening (Visit 1), during screening/baseline, and throughout the DBP.
6. Subject is able to keep accurate seizure diaries.
1. Subject is properly informed of the nature and risks of the study and gives informed
consent in writing prior to entering the study (for adult subjects) and for
adolescent subjects parent/legal guardian and subject gives informed consent or
assent in writing prior to entering the study.
2. Subject is ≥12 years of age with a BMI ≤40 kg/m2 at Visit 1.
3. 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.
4. Subject has probable or possible PGTCS (with or without other subtypes of
generalized seizures) for ≥1 year, in the setting of generalized epilepsy according
to the International League Against Epilepsy 2017 classification criteria, and
subject is approved by The Epilepsy Study Consortium (TESC).
5. Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 1 month
prior to screening (Visit 1), during screening/baseline, and throughout the DBP.
6. Subject is able to keep accurate seizure diaries.
1. Subject has had status epilepticus within the 12 months prior to Visit 1.
2. Subject has history of repetitive seizures within the 12-month period preceding
Visit 1 where the individual seizures cannot be counted.
3. Subject has a history of non-epileptic psychogenic seizures.
4. Subject has a concomitant diagnosis of focal-onset seizures (FOS).
5. Subject has presence or history of a developmental and epileptic encephalopathy,
including Lennox-Gastaut syndrome.
6. Subject has 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.
7. Subject has history of neurosurgery for seizures <1 year prior to Visit 1, or
radiosurgery <2 years prior to Visit 1.
8. Subject has schizophrenia and other psychotic disorders (eg, schizophreniform
disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar
disorder, obsessive-compulsive disorder, or another serious mental health disorder.
Subject has uncontrolled unipolar major depression where changes in pharmacotherapy
are needed or anticipated during the study.
9. Subject has any clinically significant laboratory abnormalities or clinically
significant abnormalities on prestudy physical examination, vital signs, or ECG
that, in the judgment of the investigator, indicate a medical problem that would
preclude study participation, including but not limited to:
a. History or presence of long QT syndrome; QTcF >450 msec at baseline; family
history of sudden death of unknown cause.
10. Any personal circumstance that, in the opinion of the investigator, prevents
adherence to the protocol.
The criteria to be eligible for randomization are:
1. During the last 56 days of the baseline period that preceded the randomization visit
(Visit 2), subject must have had a sufficient documented seizure frequency of PGTCS,
including ≥1 PGTCS during each of the first and second 4-week periods preceding
randomization.
2. Seizure diary was completed a minimum of 80% of all days (ie, ≥45 days) during the
last 56 days of the baseline period that preceded randomization as evidence of
adequate compliance.
3. Subject did not change dose of, stop, or initiate any new ASM(s) during the baseline
period and plans on maintaining a stable dose of ASM(s) during the DBP.