Status:
RECRUITING
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Epilepsy
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief Summary
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 partic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 8 2030
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04715646
Start Date
March 11 2021
End Date
July 8 2030
Last Update
June 27 2025
Active Locations (36)
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1
Ep0156 259
Hawthorne, New York, United States, 10532
2
Ep0156 237
Durham, North Carolina, United States, 27710
3
Ep0156 204
Leuven, Belgium
4
Ep0156 240
Prague, Czechia