A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
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
UCB Biopharma SRL
70 participants
Mar 11, 2021
INTERVENTIONAL
Conditions
Summary
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Eligibility
Inclusion Criteria5
- Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\]
- 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 Criteria9
- 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).
- \- 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)
- 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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Interventions
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
Locations(36)
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NCT04715646