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Clinical Trials in the USA / NCT04715646
Recruiting Phase 3

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

NCT04715646 · tracked via the Priya Life Science USA tracker
Sponsor
UCB Biopharma SRL
Phase
Phase 3
Started
2021-03-11
Last updated
2026-07-27

Condition(s) studied

Epilepsy

Investigational drug(s) / intervention(s)

Brivaracetam

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

Study summary

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

Eligibility

Sex
ALL
Min age
1 Month
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (36)

FacilityCityRegionStatus
Ep0156 259 Hawthorne New York Completed
Ep0156 237 Durham North Carolina Completed
Ep0156 204 Leuven Belgium Withdrawn
Ep0156 240 Prague Czechia Withdrawn
Ep0156 207 Loos France Withdrawn
Ep0156 209 Freiburg im Breisgau Germany Withdrawn
Ep0156 210 Budapest Hungary Completed
Ep0156 247 Budapest Hungary Completed
Ep0156 232 Miskolc Hungary Completed
Ep0156 230 Roma Italy Completed
Ep0156 803 Bunkyō City Japan Active Not Recruiting
Ep0156 808 Chūō Japan Active Not Recruiting
Ep0156 800 Gifu Japan Active Not Recruiting
Ep0156 807 Hiroshima Japan Active Not Recruiting
Ep0156 815 Kodaira-shi Japan Recruiting
Ep0156 813 Kōshi Japan Active Not Recruiting
Ep0156 806 Kyoto Japan Active Not Recruiting
Ep0156 811 Nagoya Japan Active Not Recruiting
Ep0156 812 Niigata Japan Active Not Recruiting
Ep0156 817 Osaka Japan Recruiting
Ep0156 818 Ōbu Japan Recruiting
Ep0156 819 Ōmura Japan Recruiting
Ep0156 805 Sapporo Japan Active Not Recruiting
Ep0156 816 Sendai Japan Recruiting
Ep0156 809 Shimotsuke Japan Active Not Recruiting
Ep0156 814 Shizuoka Japan Recruiting
Ep0156 804 Tokyo Japan Active Not Recruiting
Ep0156 810 Yokohama Japan Active Not Recruiting
Ep0156 802 Yonago Japan Completed
Ep0156 223 Aguascalientes Mexico Completed
Ep0156 609 Culiacán Mexico Completed
Ep0156 603 Guadalajara Mexico Completed
Ep0156 406 Kielce Poland Completed
Ep0156 402 Krakow Poland Completed
Ep0156 401 Poznan Poland Completed
Ep0156 248 Seville Spain Completed
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04715646 on ClinicalTrials.gov ↗ ← All trials in the USA