Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
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 France tracker
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)

  • Incidence of treatment-emergent adverse events (TEAEs) during the study — From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.
  • Incidence of treatment-emergent serious adverse events (SAEs) during the study — From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
    A serious adverse event (SAE) is any untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
  • Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study — From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug.

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 France