A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brivaracetam.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: from 1 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Czechia, France, Germany +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Detailed description
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.
Interventions
- Drug 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
Primary outcome measures
- Incidence of treatment-emergent adverse events (TEAEs) during the study [Time frame: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)]
- Incidence of treatment-emergent serious adverse events (SAEs) during the study [Time frame: 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 [Time frame: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 19 centers
- 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
- … and 11 more centers
Hungary · 3 centers
- Ep0156 210 — Budapest
- Ep0156 247 — Budapest
- Ep0156 232 — Miskolc
Mexico · 3 centers
- Ep0156 223 — Aguascalientes
- Ep0156 609 — Culiacán
- Ep0156 603 — Guadalajara
Poland · 3 centers
- Ep0156 406 — Kielce
- Ep0156 402 — Krakow
- Ep0156 401 — Poznan
United States · 2 centers
- Ep0156 259 — Hawthorne
- Ep0156 237 — Durham
Belgium · 1 center
- Ep0156 204 — Leuven
Czechia · 1 center
- Ep0156 240 — Prague
France · 1 center
- Ep0156 207 — Loos
Germany · 1 center
- Ep0156 209 — Freiburg im Breisgau
Italy · 1 center
- Ep0156 230 — Roma
Spain · 1 center
- Ep0156 248 — Seville
Identifiers
NCT: NCT04715646 · EP0156 · 2020-003664-29