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A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Primary Purpose

Childhood Absence Epilepsy, Juvenile Absence Epilepsy

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brivaracetam Film-coated tablet
Brivaracetam oral solution
Sponsored by
UCB Biopharma SRL
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Absence Epilepsy focused on measuring Childhood absence epilepsy, Juvenile absence epilepsy, Brivaracetam, Phase 3, Briviact, CAE, JAE, Epilepsy

Eligibility Criteria

2 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants who previously participated in N01269 (NCT04666610) and qualify for entry into EP0132 as per N01269 (NCT04666610) protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE), and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected, in the opinion of the Investigator
  • A sexually active male study participant must agree to use contraception during the treatment period and for at least 2 days, corresponding to the time needed to eliminate study treatment, after the last dose of study treatment and refrain from donating sperm during this period

  • A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

    1. The study participant is premenarchal OR
    2. A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the last dose of study medication, corresponding to the time needed to eliminate study treatment
  • Study participant is capable of and provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Exclusion Criteria:

  • Study participant has a history or presence of paroxysmal nonepileptic seizures
  • Study participant has severe medical, neurological, or psychiatric disorders or laboratory values, which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation
  • Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator
  • Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment
  • Study participant has active suicidal ideation prior to study entry as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) (for study participants 6 years or older) or clinical judgment (for study participants younger than 6 years). The study participant should be referred immediately to a Mental Healthcare Professional
  • Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt). The Investigator must immediately refer the study participant to a Mental Healthcare Professional
  • Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study
  • Participant has a known fructose intolerance or known hypersensitivity to any components of brivaracetam (BRV) or excipients or a drug with similar chemical structure. Note that the tablets contain lactose
  • Study participant has end-stage kidney disease requiring dialysis
  • Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin
  • Study participant has planned participation in any clinical study on an investigational drug or device
  • Study participant has poor compliance with the visit schedule or medication intake in the core study in the opinion of the Investigator

Sites / Locations

  • Ep0132 115
  • Ep0132 116
  • Ep0132 110
  • Ep0132 100
  • Ep0132 109
  • Ep0132 106
  • Ep0132 400
  • Ep0132 401
  • Ep0132 402
  • Ep0132 403
  • Ep0132 405
  • Ep0132 323
  • Ep0132 321
  • Ep0132 324
  • Ep0132 320
  • Ep0132 322
  • Ep0132 325
  • Ep0132 326
  • Ep0132 562
  • Ep0132 563
  • Ep0132 560
  • Ep0132 561
  • Ep0132 632
  • Ep0132 630
  • Ep0132 600
  • Ep0132 601
  • Ep0132 607
  • Ep0132 602

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brivaracetam arm

Arm Description

Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.

Outcomes

Primary Outcome Measures

Percentage of participants with treatment-emergent adverse events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).

Secondary Outcome Measures

Percentage of participants with 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 in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Results in permanent or significant disability/incapacity 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
Percentage of participants with study drug-related treatment-emergent adverse events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP). 'Drug related AEs' are the subset of AEs that the investigator considers as related to the study drug.
Percentage of participants with absence seizure freedom within 4 days prior to or during the 1-hour electroencephalogram (EEG) at each applicable visit
A 1-hour electroencephalogram (EEG) will be performed. The awake hours from the EEG will be analyzed for absence seizures. Every 1-hour EEG will include hyperventilation as a standard provocation test at the beginning of the EEG. Patient will be regarded as not meeting the criteria for absence seizure freedom if they received any permitted antiepileptic drugs including benzodiazepine in the 4 days prior to the EEG or during the EEG.
Percentage of participants with absence seizure freedom based on diary over the entire evaluation period and by 3-month time intervals
During the study, subjects will keep a diary to record daily seizure activity from Visit 1 until the final visit. Each seizure type experienced will be recorded. The participant will be considered as not meeting the criteria for absence seizure freedom if they use any permitted anti-epileptic drugs at anytime during the period, and/or complete less than 80% of diaries during the period.

Full Information

First Posted
October 25, 2021
Last Updated
October 17, 2023
Sponsor
UCB Biopharma SRL
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1. Study Identification

Unique Protocol Identification Number
NCT05109234
Brief Title
A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Official Title
A Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
June 25, 2024 (Anticipated)
Study Completion Date
June 25, 2024 (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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to investigate the long-term safety, tolerability and efficacy of brivaracetam in pediatric study participants with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Absence Epilepsy, Juvenile Absence Epilepsy
Keywords
Childhood absence epilepsy, Juvenile absence epilepsy, Brivaracetam, Phase 3, Briviact, CAE, JAE, Epilepsy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Brivaracetam arm
Arm Type
Experimental
Arm Description
Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.
Intervention Type
Drug
Intervention Name(s)
Brivaracetam Film-coated tablet
Intervention Description
Pharmaceutical form: Film-coated tablet Route of administration: Oral use Brivaracetam film-coated tablet [10, 25 or 50 mg] will be administered twice per day in equal doses.
Intervention Type
Drug
Intervention Name(s)
Brivaracetam oral solution
Intervention Description
Pharmaceutical form: Oral solution Route of administration: Oral use Brivaracetam oral solution [10 mg/mL]) will be administered twice per day in equal doses.
Primary Outcome Measure Information:
Title
Percentage of participants with treatment-emergent adverse events (TEAEs)
Description
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
Time Frame
From Entry Visit up to the Safety Visit (Month 26)
Title
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment
Description
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP).
Time Frame
From Entry Visit until End of Down-Titration Period (Month 26)
Secondary Outcome Measure Information:
Title
Percentage of participants with 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 in patient hospitalization or prolongation of existing hospitalization Is a congenital anomaly or birth defect Results in permanent or significant disability/incapacity 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 Entry Visit up to the Safety Visit (Month 26)
Title
Percentage of participants with study drug-related treatment-emergent adverse events (TEAEs)
Description
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory finding) in study participants, users, or other persons, whether or not related to the investigational medicinal product (IMP). 'Drug related AEs' are the subset of AEs that the investigator considers as related to the study drug.
Time Frame
From Entry Visit up to the Safety Visit (Month 26)
Title
Percentage of participants with absence seizure freedom within 4 days prior to or during the 1-hour electroencephalogram (EEG) at each applicable visit
Description
A 1-hour electroencephalogram (EEG) will be performed. The awake hours from the EEG will be analyzed for absence seizures. Every 1-hour EEG will include hyperventilation as a standard provocation test at the beginning of the EEG. Patient will be regarded as not meeting the criteria for absence seizure freedom if they received any permitted antiepileptic drugs including benzodiazepine in the 4 days prior to the EEG or during the EEG.
Time Frame
From Full Evaluation Visit (Month 6) up to the Final Visit (Month 24)
Title
Percentage of participants with absence seizure freedom based on diary over the entire evaluation period and by 3-month time intervals
Description
During the study, subjects will keep a diary to record daily seizure activity from Visit 1 until the final visit. Each seizure type experienced will be recorded. The participant will be considered as not meeting the criteria for absence seizure freedom if they use any permitted anti-epileptic drugs at anytime during the period, and/or complete less than 80% of diaries during the period.
Time Frame
From Entry Visit up to the Final Visit (Month 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants who previously participated in N01269 (NCT04666610) and qualify for entry into EP0132 as per N01269 (NCT04666610) protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE), and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected, in the opinion of the Investigator A sexually active male study participant must agree to use contraception during the treatment period and for at least 2 days, corresponding to the time needed to eliminate study treatment, after the last dose of study treatment and refrain from donating sperm during this period A female study participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: The study participant is premenarchal OR A woman of childbearing potential (WOCBP) who agrees to follow the contraceptive guidance during the treatment period and for at least 2 days after the last dose of study medication, corresponding to the time needed to eliminate study treatment Study participant is capable of and provides consent/assent, and the study participant's parent/legal representative/caregiver provides signed informed consent for minor study participants, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Exclusion Criteria: Study participant has a history or presence of paroxysmal nonepileptic seizures Study participant has severe medical, neurological, or psychiatric disorders or laboratory values, which could, at the discretion of the Investigator, affect safe participation in the study or would preclude appropriate study participation Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator's assessment Study participant has active suicidal ideation prior to study entry as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) (for study participants 6 years or older) or clinical judgment (for study participants younger than 6 years). The study participant should be referred immediately to a Mental Healthcare Professional Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt). The Investigator must immediately refer the study participant to a Mental Healthcare Professional Participant has any medical or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study Participant has a known fructose intolerance or known hypersensitivity to any components of brivaracetam (BRV) or excipients or a drug with similar chemical structure. Note that the tablets contain lactose Study participant has end-stage kidney disease requiring dialysis Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin Study participant has planned participation in any clinical study on an investigational drug or device Study participant has poor compliance with the visit schedule or medication intake in the core study in the opinion of the Investigator
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
Ep0132 115
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Ep0132 116
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States
Facility Name
Ep0132 110
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Ep0132 100
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Ep0132 109
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ep0132 106
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Ep0132 400
City
Tbilisi
Country
Georgia
Facility Name
Ep0132 401
City
Tbilisi
Country
Georgia
Facility Name
Ep0132 402
City
Tbilisi
Country
Georgia
Facility Name
Ep0132 403
City
Tbilisi
Country
Georgia
Facility Name
Ep0132 405
City
Tbilisi
Country
Georgia
Facility Name
Ep0132 323
City
Messina
Country
Italy
Facility Name
Ep0132 321
City
Milano
Country
Italy
Facility Name
Ep0132 324
City
Milano
Country
Italy
Facility Name
Ep0132 320
City
Pavia
Country
Italy
Facility Name
Ep0132 322
City
Roma
Country
Italy
Facility Name
Ep0132 325
City
Roma
Country
Italy
Facility Name
Ep0132 326
City
Verona
Country
Italy
Facility Name
Ep0132 562
City
Bucuresti
Country
Romania
Facility Name
Ep0132 563
City
Bucuresti
Country
Romania
Facility Name
Ep0132 560
City
Iasi
Country
Romania
Facility Name
Ep0132 561
City
Timişoara, Judeţ Timiş
Country
Romania
Facility Name
Ep0132 632
City
Bardejov
Country
Slovakia
Facility Name
Ep0132 630
City
Dubnica Nad Vahom
Country
Slovakia
Facility Name
Ep0132 600
City
Dnipro
Country
Ukraine
Facility Name
Ep0132 601
City
Dnipro
Country
Ukraine
Facility Name
Ep0132 607
City
Uzhgorod
Country
Ukraine
Facility Name
Ep0132 602
City
Vinnytsia
Country
Ukraine

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://vivli.org/

Learn more about this trial

A Study to Test the Long-term Safety, Tolerability and Efficacy of Brivaracetam in Study Participants 2 to 26 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

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