A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds

Официальное название

A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ONO-2017 in Japanese Patients With Partial Onset Seizures Aged 2 to Under 18 Years.

Обзор

Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures

Подробное описание

Secondary objectives:

To evaluate the efficacy of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset (focal) seizures

To evaluate the pharmacokinetics of cenobamate tablets and suspension in Japanese pediatric subjects with partial onset seizures

Вмешательства

• Препарат Cenobamate (tablet) for 12 to < 18 year olds
  The tablet form of ONO-2017 will be initiated at a dose of 12.5 mg once daily and titrated in the specified method to a target dose of 200 mg per day. The daily dose may be increased/reduced as appropriate according to symptoms within the range not exceeding 400 mg. In addition, depending on clinical response and tolerability, dose titration may be stopped at a dose of ≥ 50 mg per day to establish the maintenance dose. In principle, all doses should be taken with an appropriate amount of water i
• Препарат Cenobamate (syrup) for 2 to < 18 year olds
  The syrup form of ONO-2017 will be administered at a dose equivalent to that for 12-18 year olds on a body weight basis

Первичные конечные точки

• Adverse events and adverse drug reactions [Срок оценки: 1 year]

Критерии участия

Критерии включения

• Japanese male or female patients aged 2 to under 18 years at the time of informed consent.
• Patients diagnosed with epilepsy as having POS with uncontrolled seizures at least 6 months prior to informed consent, regardless of the presence or absence of secondarily generalized seizures.
• Patients who have had POS at least once in 4 weeks before registration. Seizure information can be obtained from the participant's own retrospective patient epilepsy diary, etc.
• Participants must have been treated with 1 to 3 ASMs at stable doses for at least 2 months before registration.

Критерии исключения

• Patients with a history of status epilepticus requiring hospitalization within 3 months before registration.
• Patients with a history of non-epileptic psychogenic seizures.
• Patients with simple partial seizures without motor symptoms or idiopathic generalized epilepsy.
• Patients diagnosed with Lennox-Gastaut syndrome.
• Patients with a history of serious drug-induced hypersensitivity reaction (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, drug-induced hypersensitivity syndrome \[DIHS\]) or drug-induced rash requiring hospitalization.

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

Япония · 1 центр

• Japan Red Cross Fukuoka Hospital — Fukuoka

Идентификаторы

NCT: NCT07594158 · ONO-2017-04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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