A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

Официальное название

Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy

Обзор

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Подробное описание

EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 \[NCG03325439\] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 \[NCT01364597\]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.

Вмешательства

• Препарат Brivaracetam
  Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses. Tablet strengths: 10 mg, 25 mg, 50 mg Route of administration: oral Oral solution Concentration: 10 mg/ml Route of administration: oral

Первичные конечные точки

• Incidence of treatment-emergent adverse events (TEAEs) during the study [Срок оценки: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)]
• Incidence of treatment-emergent serious adverse events (SAEs) during the study [Срок оценки: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)]
• Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study [Срок оценки: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)]

Критерии участия

Критерии включения

Inclusion criteria for long-term follow-up (LTFU) study participants only

• Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\]

Inclusion criteria for directly enrolled (DE) study participants in Japan only

• Study participant is ≥ 4 years to < 16 years of age
• Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
• Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)
• Study participant had at least 1 POS during the 4-week Screening Period

Критерии исключения

Exclusion criteria for all study participants

• Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
• Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).

Exclusion criteria for long-term follow-up (LTFU) study participants only

\- Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS)

Exclusion criteria for directly enrolled (DE) study participants in Japan only

• Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
• Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period
• Study participant has any clinically significant illness
• Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
• Study participant has a clinically significant ECG abnormality
• Study participant had major surgery within 6 months prior to the ScrV

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 · 19 центров

• Ep0156 803 — Bunkyō City
• Ep0156 808 — Chūō
• Ep0156 800 — Gifu
• Ep0156 807 — Hiroshima
• Ep0156 815 — Kodaira-shi
• Ep0156 813 — Kōshi
• Ep0156 806 — Kyoto
• Ep0156 811 — Nagoya
• … и ещё 11 центров

Венгрия · 3 центра

• Ep0156 210 — Budapest
• Ep0156 247 — Budapest
• Ep0156 232 — Miskolc

Мексика · 3 центра

• Ep0156 223 — Aguascalientes
• Ep0156 609 — Culiacán
• Ep0156 603 — Guadalajara

Польша · 3 центра

• Ep0156 406 — Kielce
• Ep0156 402 — Krakow
• Ep0156 401 — Poznan

США · 2 центра

• Ep0156 259 — Hawthorne
• Ep0156 237 — Durham

Бельгия · 1 центр

• Ep0156 204 — Leuven

Чехия · 1 центр

• Ep0156 240 — Prague

Франция · 1 центр

• Ep0156 207 — Loos

Германия · 1 центр

• Ep0156 209 — Freiburg im Breisgau

Италия · 1 центр

• Ep0156 230 — Roma

Испания · 1 центр

• Ep0156 248 — Seville

Идентификаторы

NCT: NCT04715646 · EP0156 · 2020-003664-29

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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