RecruitingPhase 3

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

United States, Belgium, Czechia70 participantsStarted 2021-03-11

Plain-language summary

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

Who can participate

Age range

1 Month

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 his…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of treatment-emergent adverse events (TEAEs) during the study

Timeframe: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)

Incidence of treatment-emergent serious adverse events (SAEs) during the study

Timeframe: 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

Timeframe: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)

Trial details

NCT IDNCT04715646

SponsorUCB Biopharma SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-07-08

Contact for this trial

UCB Cares

0018445992273 UCBCares@ucb.com

View on ClinicalTrials.gov More Epilepsy trials

Who can participate

Age range

1 Month

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of treatment-emergent adverse events (TEAEs) during the study

Timeframe: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)

Incidence of treatment-emergent serious adverse events (SAEs) during the study

Timeframe: 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

Timeframe: From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)