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Trial record 1 of 1 for:    EP0132
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05109234
Recruitment Status : Enrolling by invitation
First Posted : November 5, 2021
Last Update Posted : January 6, 2023
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma SRL )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Childhood Absence Epilepsy Juvenile Absence Epilepsy Drug: Brivaracetam Film-coated tablet Drug: Brivaracetam oral solution Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 30, 2022
Estimated Primary Completion Date : June 7, 2027
Estimated Study Completion Date : June 7, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Brivaracetam arm
Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.
 Drug: Brivaracetam Film-coated tablet
  • 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.


Drug: Brivaracetam oral solution
  • Pharmaceutical form: Oral solution
  • Route of administration: Oral use

Brivaracetam oral solution [10 mg/mL]) will be administered twice per day in equal doses.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: From Entry Visit up to the Safety Visit (Month 26) ]
    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).

  2. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment [ Time Frame: From Entry Visit until End of Down-Titration Period (Month 26) ]
    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 :
  1. Percentage of participants with serious adverse events (SAEs) during the study [ Time Frame: From Entry Visit up to the Safety Visit (Month 26) ]

    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

  2. Percentage of participants with study drug-related treatment-emergent adverse events (TEAEs) [ Time Frame: From Entry Visit up to the Safety Visit (Month 26) ]
    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.

  3. Percentage of participants with absence seizure freedom within 4 days prior to or during the 1-hour electroencephalogram (EEG) at each applicable visit [ Time Frame: From Full Evaluation Visit (Month 6) up to the Final Visit (Month 24) ]
    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.

  4. Percentage of participants with absence seizure freedom based on diary over the entire evaluation period and by 3-month time intervals [ Time Frame: From Entry Visit up to the Final Visit (Month 24) ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05109234


Locations
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Sponsors and Collaborators
UCB Biopharma SRL
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)
More Information
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Responsible Party: UCB Biopharma SRL
ClinicalTrials.gov Identifier: NCT05109234    
Other Study ID Numbers: EP0132
2020-002769-33 ( EudraCT Number )
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: January 6, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.
URL: https://vivli.org/

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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
Keywords provided by UCB Pharma ( UCB Biopharma SRL ):
Childhood absence epilepsy
Juvenile absence epilepsy
Brivaracetam
Phase 3
 Briviact
CAE
JAE
Epilepsy
Additional relevant MeSH terms:
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Epilepsy
Epilepsy, Absence
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Epilepsy, Generalized
Epileptic Syndromes
Brivaracetam
Anticonvulsants