RECRUITING

A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Conditions

Childhood Absence Epilepsy Juvenile Absence Epilepsy Brivaracetam Briviact Epilepsy CAE JAE

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

Official Title

A Randomized, Dose-Finding and Confirmatory, Double-Blind, Placebo-Controlled, Parallel-Group Multicenter Study With a 2 Stage Adaptive Design and Randomized Withdrawal to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Quick Facts

Study Start:2021-07-29

Study Completion:2027-02-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04666610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Years to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Study participant is 2 to 25 years of age inclusive, at the time of signing the informed consent. No study participants from 2 to \<4 years of age will be included in Stage 1 * Study participant is diagnosed with either childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE) as defined by the International League Against Epilepsy (ILAE) criteria * Study participants 2 to \<4 years of age and participants who had onset of absence seizures at an age younger than 4 years must have a negative glucose transporter type 1 deficiency syndrome (GLUT1DS) genetic test * Study participant is untreated with antiepileptic drugs (AEDs) or pretreated for absence seizures with a maximum of 2 historical AEDs, but without AED treatment for a period of at least 5 half-lives of the AED before randomization into this study. The UCB study physician should be consulted if in doubt * Study participant has electroencephalogram (EEG) evidence of bilateral synchronous, symmetric generalized paroxysmal spike waves (2.5-6 hertz) with normal background activity and with at least 1 electrographically recorded seizure lasting 3 seconds or more on a 1-hour EEG with hyperventilation (HV) while awake at Visit 1 (V1), or on a historical EEG up to 12 weeks before enrollment * Study participant has a history of clinically evident absence seizures occurring on at least 3 days per week in the 2 weeks prior to enrollment * Study participant is without treatment with psychoactive drugs or on a stable dose for at least 2 weeks prior to randomization * Study participant has normal neurological examination, head size, development and cognition * Body weight is ≥9 kg * Male and female * 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	* Study participant has a history of nonfebrile seizures other than absence seizures (eg, generalized tonic-clonic seizures or myoclonic seizures) * Study participant has a history of absence status epilepticus * Study participant has a history or presence of paroxysmal nonepileptic seizures * 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 a history of major psychiatric disease or any clinically significant medical condition that would preclude appropriate study participation * 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 judgement (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 study participant should be immediately evaluated by a Mental Healthcare Professional to address safety concerns * Study participant with known fructose intolerance or hypersensitivity of any of the ingredients in brivaracetam oral solution * Study participant has end-stage kidney disease requiring dialysis * Concomitant use of rifampicin/rifampin; prior use must have been stopped at least 2 months before randomization * Concomitant use of strong CYP2C19 inhibitors like fluconazole, fluoxetine and fluvoxamine, prior use must have been stopped at least 1 week before randomization * Study participant has participated in another study of an investigational medicinal product (IMP; and/or an investigational device) within the previous 30 days prior to informed consent * Study participant has clinical or EEG findings not consistent with a diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)

Inclusion Criteria

Exclusion Criteria

* Study participant is 2 to 25 years of age inclusive, at the time of signing the informed consent. No study participants from 2 to \<4 years of age will be included in Stage 1
* Study participant is diagnosed with either childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE) as defined by the International League Against Epilepsy (ILAE) criteria
* Study participants 2 to \<4 years of age and participants who had onset of absence seizures at an age younger than 4 years must have a negative glucose transporter type 1 deficiency syndrome (GLUT1DS) genetic test
* Study participant is untreated with antiepileptic drugs (AEDs) or pretreated for absence seizures with a maximum of 2 historical AEDs, but without AED treatment for a period of at least 5 half-lives of the AED before randomization into this study. The UCB study physician should be consulted if in doubt
* Study participant has electroencephalogram (EEG) evidence of bilateral synchronous, symmetric generalized paroxysmal spike waves (2.5-6 hertz) with normal background activity and with at least 1 electrographically recorded seizure lasting 3 seconds or more on a 1-hour EEG with hyperventilation (HV) while awake at Visit 1 (V1), or on a historical EEG up to 12 weeks before enrollment
* Study participant has a history of clinically evident absence seizures occurring on at least 3 days per week in the 2 weeks prior to enrollment
* Study participant is without treatment with psychoactive drugs or on a stable dose for at least 2 weeks prior to randomization
* Study participant has normal neurological examination, head size, development and cognition
* Body weight is ≥9 kg
* Male and female
* 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

* Study participant has a history of nonfebrile seizures other than absence seizures (eg, generalized tonic-clonic seizures or myoclonic seizures)
* Study participant has a history of absence status epilepticus
* Study participant has a history or presence of paroxysmal nonepileptic seizures
* 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 a history of major psychiatric disease or any clinically significant medical condition that would preclude appropriate study participation
* 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 judgement (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 study participant should be immediately evaluated by a Mental Healthcare Professional to address safety concerns
* Study participant with known fructose intolerance or hypersensitivity of any of the ingredients in brivaracetam oral solution
* Study participant has end-stage kidney disease requiring dialysis
* Concomitant use of rifampicin/rifampin; prior use must have been stopped at least 2 months before randomization
* Concomitant use of strong CYP2C19 inhibitors like fluconazole, fluoxetine and fluvoxamine, prior use must have been stopped at least 1 week before randomization
* Study participant has participated in another study of an investigational medicinal product (IMP; and/or an investigational device) within the previous 30 days prior to informed consent
* Study participant has clinical or EEG findings not consistent with a diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)

Contacts and Locations

Study Contact

UCB Cares

CONTACT

+1844599

UCBCares@ucb.com

Principal Investigator

UCB Cares

STUDY_DIRECTOR

001 844 599 2273 (UCB)

Study Locations (Sites)

N01269 115

Birmingham, Alabama, 35233

United States

N01269 118

Long Beach, California, 90806

United States

N01269 105

Orange, California, 92868-3874

United States

N01269 116

Denver, Colorado, 80202

United States

N01269 103

Loxahatchee Groves, Florida, 33470

United States

N01269 111

Miami, Florida, 33155-3009

United States

N01269 101

Tampa, Florida, 33612

United States

N01269 104

Winter Park, Florida, 32789

United States

N01269 110

Augusta, Georgia, 30912

United States

N01269 100

New Brunswick, New Jersey, 08901

United States

N01269 109

Winston-Salem, North Carolina, 27157

United States

N01269 106

Philadelphia, Pennsylvania, 19134

United States

Collaborators and Investigators

Sponsor: UCB Biopharma SRL

UCB Cares, STUDY_DIRECTOR, 001 844 599 2273 (UCB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-29

Study Completion Date2027-02-25

Study Record Updates

Study Start Date2021-07-29

Study Completion Date2027-02-25

Terms related to this study

Keywords Provided by Researchers

Brivaracetam
Briviact
Epilepsy
Childhood absence Epilepsy
Juvenile absence epilepsy
CAE
JAE

Additional Relevant MeSH Terms

Childhood Absence Epilepsy
Juvenile Absence Epilepsy