| Спонсоры |
Ведущий спонсор: Janssen Research & Development, LLC |
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| Источник | Janssen Research & Development, LLC |
| Краткое содержание | The purpose of this study is to evaluate the efficacy of up to 3 dose levels of adjunctive JNJ-40411813 compared to placebo based on the time to baseline monthly seizure count in participants with focal onset seizures who are receiving levetiracetam and up to 3 other anti-epileptic drugs (AEDs). |
| Общий статус | Recruiting | ||||||||||||||||||
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| Дата начала | 2021-05-18 | ||||||||||||||||||
| Дата завершения | 2024-04-01 | ||||||||||||||||||
| Дата первичного завершения | 2024-04-01 | ||||||||||||||||||
| Фаза | Phase 2 | ||||||||||||||||||
| Тип исследования | Interventional | ||||||||||||||||||
| Первичный результат |
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| Вторичный результат |
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| Регистрация | 160 |
| Состояние |
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| Вмешательство |
Тип вмешательства: Drug Название вмешательства: JNJ-40411813 Описание: JNJ-40411813 will be administered orally. Этикетка Arm Group: JNJ-40411813 Тип вмешательства: Drug Название вмешательства: Placebo Описание: Placebo will be administered orally. Этикетка Arm Group: Placebo |
| Приемлемость |
Критерии: Inclusion Criteria: - Body mass index (BMI) between 18 and 30 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2). Minimum body weight should be 40-kilogram (kg) - Established diagnosis of focal epilepsy, for at least 1 year using the International League Against Epilepsy (ILAE) criteria. Participants should not be enrolled if they are known to have had fewer than 3 or more than 100 seizures in any monthly period in the past 6 months. It is preferred that participants have experience in maintaining a seizure e-diary - Must have had a neuroimaging procedure within 10 years, including a computed tomography (CT) scan or magnetic resonance imaging (MRI), that excluded a progressive neurologic disorder; these procedures may be performed within the 8-week baseline period - Current treatment with at least 1 and up to 4 anti-epileptic drugs (AEDs) (including levetiracetam), administered at stable dosage(s) for at least 1 month before screening, and no new AEDs added for the previous 2 months; these AEDs must remain unchanged throughout the pretreatment and double-blind treatment periods (with the exception of dosage reductions of concomitant AEDs because of suspected elevated AED levels or side effects) - Currently showing inadequate response to levetiracetam, administered at the appropriate dosage(s) and for a sufficient treatment period, based on the judgment of the investigator - Healthy based on clinical laboratory tests, physical examination, medical history, vital signs, and 12-lead ECG Exclusion Criteria: - Have a generalized epileptic syndrome - Diagnosis of Lennox-Gastaut Syndrome - Currently experiencing seizures that cannot be counted accurately - History of any current or past nonepileptic seizures, including psychogenic seizures - Known allergies, hypersensitivity, or intolerance to placebo, JNJ-40411813 or its excipients - Current treatment with vagus nerve stimulation, deep brain and cortical stimulation for 1 year or less - Planned epilepsy surgery within the next 6 months or completed epilepsy surgery less than (<) 6 months ago - Current treatment with vigabatrin - History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence) - Current or past (within the past year) major psychotic disorder, such as schizophrenia, bipolar disorder, or other psychotic conditions, recent (within the past 6 months) interictal psychosis, and major depressive disorder (MDD) with psychotic features Пол: All Минимальный возраст: 18 Years Максимальный возраст: 69 Years Здоровые волонтеры: No |
| Общий Официальный |
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| Общий контакт |
Фамилия: Study Contact Телефон: 844-434-4210 |
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| Расположение |
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| Расположение Страны |
Germany Korea, Republic of Poland Russian Federation Ukraine United States |
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| Дата проверки |
2022-02-01 |
| Ответственная сторона |
Тип: Sponsor |
| Имеет расширенный доступ | No |
| Состояние Просмотр |
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| Количество рук | 2 |
| Группа вооружений |
Метка: JNJ-40411813 Тип: Experimental Описание: Participants will receive JNJ-40411813 twice a day (bid) up to 12 weeks. Up to 3 different doses (low, medium, high) of JNJ-40411813 will be administered in this study. Метка: Placebo Тип: Placebo Comparator Описание: Participants will receive Placebo bid up to 12 weeks. |
| Данные пациента | Yes |
| Информация о дизайне исследования |
Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Double (Participant, Investigator) |