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
NCT ID: NCT04666610
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
160 participants
INTERVENTIONAL
2021-07-29
2026-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo received during RDW
Randomized Withdrawal (RDW) Period:
Only study participants who are absence seizure-free based on the outcome of the 24h EEG of Visit 5 will enter the RDW Period. Study participants who are randomized to the placebo arm in the RDW Period will be tapered down to 0 mg and receive 0 mg for 2 weeks.
Brivaracetam
* Pharmaceutical form: Oral solution
* Route of administration: Oral use
Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.
Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Brivaracetam 200 mg
Placebo-Controlled (PC) and Active Treatment (AT) Period:
Stage 1: Study participants randomized to brivaracetam (BRV) 200mg/day (or equivalent dose) will receive these doses during the 2-week PC period and subsequent 11-week AT period.
Brivaracetam
* Pharmaceutical form: Oral solution
* Route of administration: Oral use
Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.
Placebo to 200 mg brivaracetam
Placebo-Controlled (PC) and Active Treatment (AT) Period:
Stage 1: Study participants randomized to 'placebo to BRV 200mg/day' (or equivalent dose) will receive placebo during the PC period followed by BRV 200mg/day (or equivalent dose) during the AT period.
Brivaracetam
* Pharmaceutical form: Oral solution
* Route of administration: Oral use
Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.
Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Brivaracetam 100 mg
Placebo-Controlled (PC) and Active Treatment (AT) Period:
Stage 1: Study participants randomized to BRV 100mg/day (or equivalent dose) will receive these doses during the 2-week PC period and subsequent 11-week AT period.
Brivaracetam
* Pharmaceutical form: Oral solution
* Route of administration: Oral use
Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.
Placebo to 100 mg brivaracetam
Placebo-Controlled (PC) and Active Treatment (AT) Period:
Stage 1: Study participants randomized to 'placebo to BRV 100mg/day' (or equivalent dose) will receive placebo during the PC period followed by BRV 100mg/day (or equivalent dose) during the AT period.
Brivaracetam
* Pharmaceutical form: Oral solution
* Route of administration: Oral use
Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.
Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Optimal dose of BRV (defined following Stage 1)
Placebo-Controlled (PC) and Active Treatment Period (AT):
Stage 2: Study participants will be randomized in Stage 2 to receive a fixed dose of the optimal dose of brivaracetam (defined following Stage 1). Study participants randomized to the BRV optimal dose will receive this dose during the 2-week PC period and subsequent 11-week AT period.
Brivaracetam
* Pharmaceutical form: Oral solution
* Route of administration: Oral use
Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.
Placebo to BRV optimal dose (defined following Stage 1)
Placebo-Controlled (PC) and Active Treatment (AT) Period:
Stage 2: Study participants will be randomized in Stage 2 of the study to 'placebo to BRV optimal dose'. Study participants randomized to placebo to brivaracetam (BRV) optimal dose will receive placebo during the PC period followed by BRV optimal dose during the AT period.
Brivaracetam
* Pharmaceutical form: Oral solution
* Route of administration: Oral use
Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.
Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Brivaracetam received during RDW
Randomized Withdrawal (RDW) Period:
Only study participants who are absence seizure-free based on the outcome of the 24h EEG of Visit 5 will enter the RDW Period. Participants who are randomized to this arm will continue on the Brivaracetam dose they were receiving in the AT period.
Brivaracetam
* Pharmaceutical form: Oral solution
* Route of administration: Oral use
Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.
Interventions
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Brivaracetam
* Pharmaceutical form: Oral solution
* Route of administration: Oral use
Brivaracetam (oral solution \[10 mg/ml, 5 mg/ml or 2.5 mg/ml\] will be administered.
Placebo
Subjects will receive placebo at pre-specified time-points to maintain the blinding.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
a) 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 b) 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 premenarchial 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 treatment, corresponding to the time needed to eliminate study treatment
* Study participant 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 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)
2 Years
25 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
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N01269 115
Birmingham, Alabama, United States
N01269 118
Long Beach, California, United States
N01269 105
Orange, California, United States
N01269 116
Denver, Colorado, United States
N01269 103
Loxahatchee Groves, Florida, United States
N01269 111
Miami, Florida, United States
N01269 101
Tampa, Florida, United States
N01269 104
Winter Park, Florida, United States
N01269 110
Augusta, Georgia, United States
N01269 100
New Brunswick, New Jersey, United States
N01269 109
Winston-Salem, North Carolina, United States
N01269 106
Philadelphia, Pennsylvania, United States
N01269 203
Heidelberg, , Australia
N01269 202
Melbourne, , Australia
N01269 200
Randwick, , Australia
N01269 201
South Brisbane, , Australia
N01269 301
Brussels, , Belgium
N01269 300
Edegem, , Belgium
N01269 400
Tbilisi, , Georgia
N01269 401
Tbilisi, , Georgia
N01269 402
Tbilisi, , Georgia
N01269 403
Tbilisi, , Georgia
N01269 405
Tbilisi, , Georgia
N01269 323
Messina, , Italy
N01269 321
Milan, , Italy
N01269 324
Milan, , Italy
N01269 320
Pavia, , Italy
N01269 322
Roma, , Italy
N01269 325
Roma, , Italy
N01269 326
Verona, , Italy
N01269 533
Gdansk, , Poland
N01269 530
Krakow, , Poland
N01269 534
Lodz, , Poland
N01269 531
Lublin, , Poland
N01269 532
Warsaw, , Poland
N01269 562
Bucharest, , Romania
N01269 563
Bucharest, , Romania
N01269 560
Iași, , Romania
N01269 561
Timişoara, Judeţ Timiş, , Romania
N01269 632
Bardejov, , Slovakia
N01269 630
Dubnica nad Váhom, , Slovakia
N01269 631
Nové Zámky, , Slovakia
N01269 351
Madrid, , Spain
N01269 353
Seville, , Spain
N01269 354
Terrassa, , Spain
N01269 600
Dnipro, , Ukraine
N01269 601
Dnipro, , Ukraine
N01269 604
Kharkiv, , Ukraine
N01269 608
Kharkiv, , Ukraine
N01269 603
Kyiv, , Ukraine
N01269 606
Kyiv, , Ukraine
N01269 607
Uzhhorod, , Ukraine
N01269 602
Vinnytsia, , Ukraine
Countries
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Central Contacts
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References
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Bast T, Schulz AL, Floricel F, Morita D, Cleveland JM, Elshoff JP. Efficacy and tolerability of brivaracetam monotherapy in childhood and juvenile absence epilepsy: An innovative adaptive trial design. Epilepsia Open. 2022 Dec;7(4):588-597. doi: 10.1002/epi4.12628. Epub 2022 Aug 4.
Other Identifiers
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2020-002750-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-510428-55-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1303-2521
Identifier Type: OTHER
Identifier Source: secondary_id
N01269
Identifier Type: -
Identifier Source: org_study_id
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