Childhood Absence EpilepsyPhase 3EXPANDNCT04666610
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
A Phase 3 study testing Brivaracetam in people with Childhood Absence Epilepsy and Juvenile Absence Epilepsy, run by UCB Biopharma SRL at 35 sites in 7 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Childhood Absence Epilepsy, Juvenile Absence Epilepsy
- What is being tested?
- Brivaracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 35 sitesin 7 countries
- Study dates
- 29 Jul 2021to 7 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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 more than or equal to 9 kg
- Male and female
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
35 sites in 7 countries.
35 sites in 7 countries
United States10 sites
N01269 110
Augusta, Georgia, 30912
N01269 115
Birmingham, Alabama, 35233
N01269 116
Denver, Colorado, 80202
N01269 111
Miami, Florida, 33155-3009
N01269 100
New Brunswick, New Jersey, 08901
N01269 105
Orange, California, 92868-3874
N01269 106
Philadelphia, Pennsylvania, 19134
N01269 101
Tampa, Florida, 33612
N01269 109
Winston-Salem, North Carolina, 27109
N01269 104
Winter Park, Florida, 32789
Italy7 sites
N01269 323
Messina
N01269 321
Milan
N01269 324
Milan
N01269 320
Pavia
N01269 322
Roma
N01269 325
Roma
N01269 326
Verona
Georgia5 sites
N01269 400
Tbilisi
N01269 401
Tbilisi
N01269 402
Tbilisi
N01269 403
Tbilisi
N01269 405
Tbilisi
Ukraine5 sites
N01269 600
Dnipro
N01269 601
Dnipro
N01269 604
Kharkiv
N01269 607
Uzhhorod
N01269 602
Vinnytsia
Romania4 sites
N01269 562
Bucharest
N01269 563
Bucharest
N01269 560
Iași
N01269 561
Timişoara, Judeţ Timiş
Slovakia3 sites
N01269 632
Bardejov
N01269 630
Dubnica nad Váhom
N01269 631
Nové Zámky
About this study
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
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).
- Being tested
- Brivaracetam, Placebo
- Keywords
- Brivaracetam, Briviact, Epilepsy, Childhood absence Epilepsy, Juvenile absence epilepsy, CAE, JAE
- Medical subject headings
- Epilepsy, Absence, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrivaracetamDrug
Also called BRV
- 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.
PlaceboOther
Also called PBO
Subjects will receive placebo at pre-specified time-points to maintain the blinding.
| Study group | Role | What they receive |
|---|---|---|
| Brivaracetam 200 mg | Experimental | 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. Receives: Drug: Brivaracetam |
| Placebo to 200 mg brivaracetam | Experimental | 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. Receives: Drug: Brivaracetam; Other: Placebo |
| Brivaracetam 100 mg | Experimental | 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. Receives: Drug: Brivaracetam |
| Placebo to 100 mg brivaracetam | Experimental | 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. Receives: Drug: Brivaracetam; Other: Placebo |
| Optimal dose of BRV (defined following Stage 1) | Experimental | 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. Receives: Drug: Brivaracetam |
| Placebo to BRV optimal dose (defined following Stage 1) | Experimental | 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. Receives: Drug: Brivaracetam; Other: Placebo |
| Brivaracetam received during RDW | Experimental | 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. Receives: Drug: Brivaracetam |
| Placebo received during RDW | Experimental | 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. Receives: Drug: Brivaracetam; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who met the criteria for absence seizure freedom within 4 days prior to or during the 24-hour ambulatory electroencephalogram (EEG) at Day 14
A 24-hour ambulatory electroencephalogram (EEG) will be performed at day 14. The awake hours from the EEG will be analyzed for absence seizures. Every 24-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 benzodiazepine in the 4 days prior to the EEG or during the EEG.
Measured: Day 14
Secondary outcomes (9)
Percentage of participants who met the criteria for absence seizure freedom during the randomized withdrawal (RDW) period as determined by electroencephalogram (EEG)
Study participants (or their care givers) who believe they are experiencing a recurrence of absence seizures will contact the clinical site for a 1-hour EEG (with hyperventilation (HV)). If no absence seizure is observed during this 1hr EEG (locally read), the study participant will receive a 24-hour ambulatory EEG. If an absence seizure is observed during either EEG, the study participant will be considered as not Absence seizure free and leave the study. If no absence seizures are determined by 1/24hr ambulatory EEG the participant will conduct a 24-hour EEG at week 17. Patient will be regarded as not meeting the criteria for absence seizure freedom if they received benzodiazepine in the 4 days prior to the EEG or during the EEG.
The awake hours from the EEG will be analyzed for absence seizures. Every 24-hour EEG will include HV as a standard provocation test at the beginning of the EEG.
Measured: From Week 13 to Week 17
Percent change from Baseline to Day 14 in number of absence seizures on 24-hour ambulatory electroencephalogram (EEG)
A 24-hour ambulatory electroencephalogram (EEG) will be performed at baseline and day 14. The awake hours from the EEG will be analyzed for absence seizures. Every 24-hour EEG will include hyperventilation as a standard provocation test at the beginning of the EEG.
This endpoint is the difference between the number of seizures at baseline and Day 14.
Measured: From Baseline to Day 14
Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Day 14
During the study subjects will keep a diary to record daily seizure activity from Visit 1 until end of the randomized withdrawal (RDW) Period. Each seizure type experienced will be recorded. The last 4 study days prior to Day 14 EEG are used for this endpoint.
Patient will be regarded as not meeting the criteria for absence seizure freedom if they received benzodiazepine in the 4 days prior to the EEG or during the EEG.
Measured: Day 14
Percentage of participants who met the criteria for absence seizure freedom on 24-hour ambulatory electroencephalogram (EEG) at Week 12
A 24-hour ambulatory electroencephalogram (EEG) will be performed at day 14. The awake hours from the EEG will be analyzed for absence seizures. Every 24-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 benzodiazepine in the 4 days prior to the EEG or during the EEG.
Measured: Week 12
Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Week 12
During the study subjects will keep a diary to record daily seizure activity from Visit 1 until end of the randomized withdrawal (RDW) Period. Each seizure type experienced will be recorded. The last 4 study days prior to Week 12 EEG are used for this endpoint. Patient will be regarded as not meeting the criteria for absence seizure freedom if they received benzodiazepine in the 4 days prior to the EEG or during the EEG.
Measured: Week 12
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
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).
Measured: From Day 1 until End of Safety Follow-Up (up to Week 23)
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).
Measured: From Day 1 until End of Down Titration Period (up to Week 21)
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
Measured: From Screening Period (Day -14 to Day -2) until End of Safety Follow-Up (up to Week 23)
Percentage of participants with drug-related treatment-emergent adverse events (TEAEs) during the study
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.
Measured: From Baseline (Day -1) until End of Safety Follow-Up (up to Week 23)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start29 Jul 2021
- Primary completion7 Jul 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood Absence EpilepsyStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666610
- Sponsor's protocol ID
- N01269
- Other IDs
- 2020-002750-24, 2023-510428-55-00, U1111-1303-2521, 2023
- Acronym
- EXPAND
- Status last verified
- Oct 2026
- First submitted
- 7 Dec 2020
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available
Publications
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.
PubMed 35844134
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04666610
- Acronym / sponsor ID
- EXPAND / N01269
- Keywords
- Brivaracetam, Briviact, Epilepsy, Childhood absence Epilepsy, Juvenile absence epilepsy, CAE, JAE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Brivaracetam 200 mg | Experimental | Drug: BrivaracetamPlacebo-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. |
| Placebo to 200 mg brivaracetam | Experimental | Drug: Brivaracetam, Other: PlaceboPlacebo-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 100 mg | Experimental | Drug: BrivaracetamPlacebo-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. |
| Placebo to 100 mg brivaracetam | Experimental | Drug: Brivaracetam, Other: PlaceboPlacebo-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. |
| Optimal dose of BRV (defined following Stage 1) | Experimental | Drug: BrivaracetamPlacebo-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. |
| Placebo to BRV optimal dose (defined following Stage 1) | Experimental | Drug: Brivaracetam, Other: PlaceboPlacebo-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 received during RDW | Experimental | Drug: BrivaracetamRandomized 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. |
| Placebo received during RDW | Experimental | Drug: Brivaracetam, Other: PlaceboRandomized 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. |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrivaracetamAlso: BRV* 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. | Drug | Brivaracetam 100 mg, Brivaracetam 200 mg, Brivaracetam received during RDW, Optimal dose of BRV (defined following Stage 1), Placebo received during RDW, Placebo to 100 mg brivaracetam, Placebo to 200 mg brivaracetam, Placebo to BRV optimal dose (defined following Stage 1) |
| PlaceboAlso: PBOSubjects will receive placebo at pre-specified time-points to maintain the blinding. | Other | Placebo received during RDW, Placebo to 100 mg brivaracetam, Placebo to 200 mg brivaracetam, Placebo to BRV optimal dose (defined following Stage 1) |
Primary outcome
Percentage of participants who met the criteria for absence seizure freedom within 4 days prior to or during the 24-hour ambulatory electroencephalogram (EEG) at Day 14
Time frame: Day 14
A 24-hour ambulatory electroencephalogram (EEG) will be performed at day 14. The awake hours from the EEG will be analyzed for absence seizures. Every 24-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 benzodiazepine in the 4 days prior to the EEG or during the EEG.
9 secondary outcomes
Percentage of participants who met the criteria for absence seizure freedom during the randomized withdrawal (RDW) period as determined by electroencephalogram (EEG)
Time frame: From Week 13 to Week 17
Percent change from Baseline to Day 14 in number of absence seizures on 24-hour ambulatory electroencephalogram (EEG)
Time frame: From Baseline to Day 14
Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Day 14
Time frame: Day 14
Percentage of participants who met the criteria for absence seizure freedom on 24-hour ambulatory electroencephalogram (EEG) at Week 12
Time frame: Week 12
Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Week 12
Time frame: Week 12
Percentage of participants with treatment-emergent adverse events (TEAEs) during the study
Time frame: From Day 1 until End of Safety Follow-Up (up to Week 23)
Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment
Time frame: From Day 1 until End of Down Titration Period (up to Week 21)
Percentage of participants with serious adverse events (SAEs) during the study
Time frame: From Screening Period (Day -14 to Day -2) until End of Safety Follow-Up (up to Week 23)
Percentage of participants with drug-related treatment-emergent adverse events (TEAEs) during the study
Time frame: From Baseline (Day -1) until End of Safety Follow-Up (up to Week 23)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Results publication: PubMed 35844134Bast 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.
- Individual participant dataSharing planned: Yes. 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.
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RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingPhase 3
A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Childhood Absence Epilepsy, Juvenile Absence Epilepsy
RecruitingPhase 3
Ketogenic Diet for New-Onset Absence Epilepsy
Absence Epilepsy, Ketogenic Dieting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brivaracetam in people with Childhood Absence Epilepsy and Juvenile Absence Epilepsy, run by UCB Biopharma SRL at 35 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Italy, Georgia, Ukraine, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who met the criteria for absence seizure freedom within 4 days prior to or during the 24-hour ambulatory electroencephalogram (EEG) at Day 14 (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666610, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.