Идёт набор NCT06999902
Double-blind, Randomized Trial of PRAX-628 in Adults With Focal Seizures to Evaluate Efficacy and Safety (POWER1)
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: 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks, Placebo.
- Кому может быть актуально
- Состояния в реестре: Focal Seizure. Базовые параметры: 18 лет — 75 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, Испания
- 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 Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)
Обзор
A Double-Blind, Randomized, Multicenter, Trial Evaluating the Efficacy and Safety of PRAX-628 in Adults With Focal Seizures (POWER1)
Подробное описание
PRAX-628-321 (POWER1) is a double-blind, randomized, multicenter, trial to evaluate the efficacy and safety of PRAX-628 in adults who can attest to concurrently taking at least 1, but no more than 3 acceptable anti-seizure medications.
Вмешательства
- Препарат 20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks
Once daily oral - Препарат Placebo
Once daily oral
Первичные конечные точки
- To evaluate the efficacy of PRAX-628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs [Срок оценки: 12 weeks]
Вторичные конечные точки (11)
- To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs [Срок оценки: 12 weeks]
- To assess trends over time in efficacy of PRAX 628 on focal seizure frequency [Срок оценки: 12 weeks]
- To evaluate the efficacy of PRAX 628 compared to placebo on focal seizure frequency in adults currently taking 1 to 3 ASMs [Срок оценки: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Срок оценки: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Срок оценки: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Срок оценки: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Срок оценки: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Срок оценки: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Срок оценки: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Срок оценки: 12 weeks]
- To assess the safety and tolerability of PRAX-628 in adults with focal seizures [Срок оценки: 12 weeks]
Критерии участия
Критерии включения
- A diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy.
- Past evidence by computed tomography (CT) or magnetic resonance imaging (MRI) that has ruled out a progressive cause of epilepsy in the judgement of the investigator and/or in consultation with the medical monitor.
Критерии исключения
- Subject has had any of the of the following within the 12-month period preceding trial entry: History of pseudo or psychogenic seizures, cluster seizures where the individual seizures cannot be counted, an episode of convulsive status epilepticus requiring hospitalization and intubation, or subject only has focal seizures with awareness that do not have motor activity.
- Planned epilepsy surgery during the course of the clinical trial.
- History of neurosurgery for seizures <1 year prior to enrollment, or radiosurgery <2 years prior to enrollment or vagus nerve stimulation (VNS) implantation.
- History of schizophrenia, obsessive-compulsive disorder, or other serious mental health disorders.
- History of malignancy, myeloproliferative or lymphoproliferative disorders within the past 5 years are excluded.
- History of cardiac disease(s)/cardiac conduction disorders/or cardiac structural abnormality(ies).
- Has a positive test result or a known history of a positive test result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitis C virus (HCV) antibody at Screening.
- Is pregnant or is breastfeeding at the time of Screening or has a positive serum pregnancy test at Screening or is planning to become pregnant during the clinical trial or within 14 days of the last study drug dose.
- Has received any other experimental or investigational drug, device or other therapy within 30 days or 5 half-lives (whichever is longer) prior to Screening, or any prior use of gene therapy.
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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 16 центров
- Praxis Research Site — Phoenix
- Praxis Research Site — DeLand
- Praxis Research Site — Miami Lakes
- Praxis Research Site — Chicago
- Praxis Research Site — Lafayette
- Praxis Research Site — Bethesda
- Praxis Research Site — Chesterfield
- Praxis Research Site — Ozark
- … и ещё 8 центров
Испания · 10 центров
- Praxis Research Site — Barcelona
- Praxis Research Site — Barcelona
- Praxis Research Site — Barcelona
- Praxis Research Site — Granda
- Praxis Research Site — Madrid
- Praxis Research Site — Madrid
- Praxis Research Site — Madrid
- Praxis Research Site — Málaga
- … и ещё 2 центра
Идентификаторы
NCT: NCT06999902 · PRAX-628-321