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

Primary Purpose

Epilepsy

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brivaracetam
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Brivaracetam, Pediatric, Child

Eligibility Criteria

1 Month - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ep0156 259
  • Ep0156 237
  • Ep0156 210
  • Ep0156 247
  • Ep0156 232
  • Ep0156 230
  • Ep0156 803
  • Ep0156 808
  • Ep0156 800
  • Ep0156 807
  • Ep0156 813
  • Ep0156 806
  • Ep0156 811
  • Ep0156 812
  • Ep0156 805
  • Ep0156 809
  • Ep0156 804
  • Ep0156 810
  • Ep0156 802
  • Ep0156 223
  • Ep0156 609
  • Ep0156 603
  • Ep0156 406
  • Ep0156 402
  • Ep0156 401
  • Ep0156 248

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brivaracetam

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2021
Last Updated
July 27, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT04715646
Brief Title
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
July 17, 2029 (Anticipated)
Study Completion Date
July 17, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Biopharma SRL

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Brivaracetam, Pediatric, Child

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brivaracetam
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Brivaracetam
Other Intervention Name(s)
BRV, Briviact
Intervention Description
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
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs) during the study
Description
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.
Time Frame
From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
Title
Incidence of treatment-emergent serious adverse events (SAEs) during the study
Description
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
Time Frame
From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)
Title
Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study
Description
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.
Time Frame
From Evaluation Visit (Day 1) until Safety Visits (up to 5 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
Facility Name
Ep0156 259
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
Ep0156 237
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ep0156 210
City
Budapest
Country
Hungary
Facility Name
Ep0156 247
City
Budapest
Country
Hungary
Facility Name
Ep0156 232
City
Miskolc
Country
Hungary
Facility Name
Ep0156 230
City
Roma
Country
Italy
Facility Name
Ep0156 803
City
Bunkyo-ku
Country
Japan
Facility Name
Ep0156 808
City
Chuo
Country
Japan
Facility Name
Ep0156 800
City
Gifu-City
Country
Japan
Facility Name
Ep0156 807
City
Hiroshima
Country
Japan
Facility Name
Ep0156 813
City
Koshi
Country
Japan
Facility Name
Ep0156 806
City
Kyoto
Country
Japan
Facility Name
Ep0156 811
City
Nagoya
Country
Japan
Facility Name
Ep0156 812
City
Niigata-city
Country
Japan
Facility Name
Ep0156 805
City
Sapporo-city
Country
Japan
Facility Name
Ep0156 809
City
Shimotsuke
Country
Japan
Facility Name
Ep0156 804
City
Tokyo
Country
Japan
Facility Name
Ep0156 810
City
Yokohama
Country
Japan
Facility Name
Ep0156 802
City
Yonago
Country
Japan
Facility Name
Ep0156 223
City
Aguascalientes
Country
Mexico
Facility Name
Ep0156 609
City
Culiacan
Country
Mexico
Facility Name
Ep0156 603
City
Guadalajara
Country
Mexico
Facility Name
Ep0156 406
City
Kielce
Country
Poland
Facility Name
Ep0156 402
City
Krakow
Country
Poland
Facility Name
Ep0156 401
City
Poznan
Country
Poland
Facility Name
Ep0156 248
City
Sevilla
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://www.Vivli.org

Learn more about this trial

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

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