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

RecruitingPhase 3Ages 1 Month - anyAllUCB Biopharma SRL
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: Inclusion criteria for long-term follow-up (LTFU) study participants only * Study participants โ‰ฅ 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 โ‰ฅ 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 โ‰ฅ 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
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What it tests

  • Brivaracetam
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Where

36 sites
Ep0156 259
Hawthorne, United States
Ep0156 237
Durham, United States
Ep0156 204
Leuven, Belgium
Ep0156 240
Prague, Czechia
Ep0156 207
Loos, France
Ep0156 209
Freiburg im Breisgau, Germany
Ep0156 210
Budapest, Hungary
Ep0156 247
Budapest, Hungary

โ€ฆand 28 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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