A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: XEN1101, Placebo.
- Кому может быть актуально
- Состояния в реестре: Focal Onset Seizures. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Аргентина, Австралия, Австрия, Бельгия +15
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат XEN1101
XEN1101 Capsules - Препарат Placebo
Placebo Capsules
Первичные конечные точки
- Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo. [Срок оценки: From baseline through to the double blind period (week 12).]
Вторичные конечные точки (4)
- Proportion of subjects experiencing ≥50% reduction in focal seizure frequency from baseline through the DBP for XEN1101 versus placebo. [Срок оценки: 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. [Срок оценки: 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). [Срок оценки: From baseline through to the double blind period (week 12).]
- To assess adverse events as criteria for safety and tolerability of XEN1101. [Срок оценки: From screening through to 56 days post-final dose]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 19 центров
- 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
- … и ещё 11 центров
Аргентина · 12 центров
- 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.
- … и ещё 4 центра
Португалия · 8 центров
Список центров уточняется — проверьте первичный протокол.
Австралия · 6 центров
- Royal Prince Alfred Hospital — Camperdown
- Prince of Wales Hospital — Randwick
- Westmead Hospital — Westmead
- Alfred Hospital — Melbourne
- Austin Health — Melbourne
- Royal Melbourne Hospital — Melbourne
Франция · 6 центров
- 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
Хорватия · 5 центров
- 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
Польша · 5 центров
- COPERNICUS Podmiot Leczniczy — Gdansk
- NZOZ Neuromed M. i M. Nastaj Sp. P. — Lublin
- … и ещё 3 центра
Чили · 4 центра
- Clinica Universidad de Los Andes — Santiago
- Centro de Investigacion Clinica UC — Santiago
- CINSAN — Santiago
- Hospital Clínico Viña del Mar — Viña del Mar
Израиль · 4 центра
- Hadassah Medical Center — Jerusalem
- The Chaim Sheba Medical Center — Ramat Gan
- Kaplan Medical Center — Rehovot
- The Tel Aviv Sourasky Medical Center — Tel Aviv
Мексика · 4 центра
- 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
Испания · 4 центра
Список центров уточняется — проверьте первичный протокол.
Австрия · 3 центра
- University Hospital Innsbruck — Innsbruck
- Universitätsklinik für Neurologie — Salzburg
- Medical University of Vienna — Vienna
Чехия · 3 центра
- EUC Hradec Kralove Clinic — Hradec Králové
- Nemocnicni lekarna FN Motol / Motol University Hospital — Prague
- Forbeli s.r.o. — Prague
Германия · 3 центра
- Universitätsklinikum Aachen — Aachen
- Krankenhaus Mara gGmbH — Bielefeld
- University Hospital Frankfurt, ZNN - Epilepsy Center Frankfurt Rhine-Main — Frankfurt
Бельгия · 2 центра
- Cliniques Universitaires Saint-Luc (UCL) — Brussels
- Universitair Ziekenhuis Gent — Ghent
Болгария · 2 центра
- MHATNPsy Sveti Naum EAD — Sofia
- Medical center OPHTHA-NEURO — Sofia
Италия · 2 центра
- Ospedali Riuniti di Ancona — Ancona
- Università degli studi di Bari Aldo Moro — Bari
Финляндия · 1 центр
- Kuopio University Hospital — Kuopio
Венгрия · 1 центр
- Semmelweis Egyetem, Idegsebészeti és Neurointervenciós Klinika — Budapest
Нидерланды · 1 центр
- Kempenhaeghe — Heeze
Идентификаторы
NCT: NCT05716100 · XPF-010-302 · 2022-502281-25-00