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

NCT04715646 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: EP01562020-003664-29
• Study Type: interventional
• Target: 70
• Locations: 11 countries
• Sites: 36

Brief Summary

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

Conditions

Epilepsy

Keywords

Epilepsy; Brivaracetam; Pediatric; Child

Outcome Measures

Primary Outcomes (3)

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

  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.

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

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

  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

  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

  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.

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

Study Arms (1)

Brivaracetam

EXPERIMENTAL

LTFU study participants: Up to 5mg/kg/day (for study participants weighing 11kg to less than 20kg) and up to 4mg/kg/day (for study participants weighing 20kg to less than 50kg) and no more than 200mg/day Directly enrolled (DE) study participants: 1mg/kg/day to 4mg/kg/day and no more than 200mg/day.

Drug: Brivaracetam

Interventions

Brivaracetam DRUG

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

Also known as: BRV, Briviact

Brivaracetam

Eligibility Criteria

• Age: 1 Month+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (36)

Ep0156 259

Hawthorne, New York, 10532, United States

COMPLETED

Ep0156 237

Durham, North Carolina, 27710, United States

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

MeSH Terms

Conditions

Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Central Study Contacts

UCB Cares

CONTACT

0018445992273; UCBCares@ucb.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: January 20, 2021
• Study Start: March 11, 2021
• Primary Completion (Estimated): July 8, 2030
• Study Completion (Estimated): July 8, 2030
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
• Access Criteria: Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

Locations

BE (1); FR (1); HU (3); IT (1); CZ (1); JP (19); PL (3); ES (1); DE (1); ME (3); US (2)