Идёт набор NCT07219407
A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures
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: RAP-219.
- Кому может быть актуально
- Состояния в реестре: Focal Epilepsy, Epilepsy, Refractory Focal Epilepsy, Seizure. Базовые параметры: 18 лет — 70 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
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
An Open-label, Long-term Study Evaluating RAP-219 in Adult Participants With Refractory Onset Seizures
Обзор
This is a clinical research study for an investigational drug called RAP-219 in patients with Refractory Focal Epilepsy. This study is being conducted to determine RAP-219 Long- term safety and open-label antiseizure activity in patients with Refractory Focal Epilepsy.
Подробное описание
This is a multi-center, open-label study to evaluate the long-term safety, tolerability, pharmacokinetics, pharmacodynamics and antiseizure activity of RAP-219 in adult participants with refractory focal seizures
Вмешательства
- Препарат RAP-219
Participants will receive one RAP-219 0.125 mg capsule daily for 3 days followed by one 0.25mg tablet RAP-219 daily for 28 days, then one 0.75mg tablet daily for the remainder of the treatment period.
Первичные конечные точки
- Incidence of treatment-emergent adverse events (TEAEs) [Срок оценки: From the start of RAP-219 treatment through 8 weeks after last dose, up to Week 112]
Вторичные конечные точки (12)
- Percent change in clinical seizure frequency [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Clinical seizure 25%, 50%, 75%, and 100% responder proportions [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Change in clinical seizure-free day frequency [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Longest clinical seizure-free interval [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Time to pre-randomization clinical seizure count [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- RNS long episode 30%, 50%, 75% or with 100% responder proportions [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Percent change in RNS long episode frequency [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Change in RNS long episode-free day frequency [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Longest RNS long episode-free interval [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Time to pre-randomization long episode count [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Percent change in RNS estimated electrographic seizure frequency [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
- Clinical Global Impression of Change (CGI-C) responder count and proportions [Срок оценки: Throughout the open-label period until 8 weeks after the last dose, up to Week 112, compared to the pre-treatment baseline period.]
Критерии участия
Критерии включения
- Completion of the associated parent study (RAP-219-FOS-201) treatment period with acceptable tolerability, per Investigator.
- Diagnosis of refractory focal epilepsy
- Stable RNS(c) system settings
- A demonstrated history of compliance with RNS(c) system data interrogation and upload
- Good overall health other than focal epilepsy, per Investigator.
- BMI ≥ 18 kg/m\^2 and ≤ 45 kg/m\^2
- Willing and able to adhere to all aspects of the protocol.
Критерии исключения
- Known of hypersensitivity to RAP-219
- Any clinically unstable or serious medical, neurological (other than epilepsy), psychological, or behavioral problem; laboratory or ECG finding that would increase participant risk or should otherwise exclude the patient from participation, as assessed by Investigator
- Pregnancy, lactation, or individuals of reproductive potential who do not agree to simultaneously use two effective birth-control methods
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 7 центров
- Consultants in Epilepsy and Neurology, PLLC — Boise
- Mayo Clinic — Rochester
- NYU Langone Comprehensive Epilepsy Center — New York
- Cleveland Clinic Foundation — Cleveland
- University of Pennsylvania - Department of Neurology — Philadelphia
- Vanderbilt University Medical Center — Nashville
- Baylor College of Medicine — Houston
Идентификаторы
NCT: NCT07219407 · RAP-219-FOS-901