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

Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy

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

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Drug: 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 participated in the open-label, long-term, follow-up pediatric study N01266 [NCT01364597]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: UCB Cares; Phone Number: 0018445992273; Email: UCBCares@ucb.com

Study Locations

• Belgium
  • Leuven, Belgium
    • Withdrawn
    • Ep0156 204
• Czechia
  • Praha 4, Czechia
    • Withdrawn
    • Ep0156 240
• France
  • Loos, France
    • Withdrawn
    • Ep0156 207
• Germany
  • Freiburg, Germany
    • Withdrawn
    • Ep0156 209
• Hungary
  • Budapest, Hungary
    • Completed
    • Ep0156 210
  • Budapest, Hungary
    • Completed
    • Ep0156 247
  • Miskolc, Hungary
    • Completed
    • Ep0156 232
• Italy
  • Roma, Italy
    • Completed
    • Ep0156 230
• Japan
  • Bunkyo-ku, Japan
    • Active, not recruiting
    • Ep0156 803
  • Chuo, Japan
    • Active, not recruiting
    • Ep0156 808
  • Gifu-City, Japan
    • Active, not recruiting
    • Ep0156 800
  • Hiroshima, Japan
    • Active, not recruiting
    • Ep0156 807
  • Kodaira-shi, Japan
    • Recruiting
    • Ep0156 815
  • Koshi, Japan
    • Active, not recruiting
    • Ep0156 813
  • Kyoto, Japan
    • Active, not recruiting
    • Ep0156 806
  • Nagoya, Japan
    • Active, not recruiting
    • Ep0156 811
  • Niigata-city, Japan
    • Active, not recruiting
    • Ep0156 812
  • OBU, Japan
    • Recruiting
    • Ep0156 818
  • Omura, Japan
    • Recruiting
    • Ep0156 819
  • Osaka, Japan
    • Recruiting
    • Ep0156 817
  • Sapporo-city, Japan
    • Active, not recruiting
    • Ep0156 805
  • Sendai-shi, Japan
    • Recruiting
    • Ep0156 816
  • Shimotsuke, Japan
    • Active, not recruiting
    • Ep0156 809
  • Shizuoka, Japan
    • Recruiting
    • Ep0156 814
  • Tokyo, Japan
    • Active, not recruiting
    • Ep0156 804
  • Yokohama, Japan
    • Active, not recruiting
    • Ep0156 810
  • Yonago, Japan
    • Completed
    • Ep0156 802
• Mexico
  • Aguascalientes, Mexico
    • Completed
    • Ep0156 223
  • Culiacan, Mexico
    • Completed
    • Ep0156 609
  • Guadalajara, Mexico
    • Completed
    • Ep0156 603
• Poland
  • Kielce, Poland
    • Completed
    • Ep0156 406
  • Krakow, Poland
    • Completed
    • Ep0156 402
  • Poznan, Poland
    • Completed
    • Ep0156 401
• Spain
  • Sevilla, Spain
    • Completed
    • Ep0156 248
• United States
  • New York
    • Hawthorne, New York, United States, 10532
      • Completed
      • Ep0156 259
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Completed
      • Ep0156 237

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brivaracetam; 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; 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; Other Names: Briviact; BRV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: UCB Biopharma SRL
• Investigators: Study Director: UCB Cares, 001 844 599 2273 (UCB)

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2021
• Primary Completion (Estimated): July 8, 2030
• Study Completion (Estimated): July 8, 2030

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 27, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Epilepsy; Child; Pediatric; Brivaracetam
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Anticonvulsants; Brivaracetam
• Other Study ID Numbers: EP0156; 2020-003664-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, 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 prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No