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

NCT05109234 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: EP01322020-002769-33
• Study Type: interventional
• Target: 84
• Locations: 6 countries
• Sites: 24

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).

Conditions

Childhood Absence Epilepsy; Juvenile Absence Epilepsy

Keywords

Childhood absence epilepsy; Juvenile absence epilepsy; Brivaracetam; Phase 3; Briviact; CAE; JAE; Epilepsy

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are defined as AEs that had onset on or after the day of first dose of BRV.

  From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months

• Percentage of Participants With TEAEs Leading to Discontinuation of Study Treatment

  An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. TEAEs are defined as AEs that had onset on or after the day of first dose of BRV. Percentage of participants with TEAEs leading to discontinuation were reported.

  From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months

Secondary Outcomes (4)

• Percentage of Participants With Serious TEAEs

  From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months

• Percentage of Participants With Study Drug-related TEAEs

  From Entry Visit up to 16.32 months (median); min, max exposure to BRV was (0.4, 31.0) months

• Percentage of Participants With Absence Seizure Freedom Within 4 Days Prior to or During the 1-hour Electroencephalogram (EEG)

  Full Evaluation Visit (6 months), Yearly Evaluation Visit (12 months), Full Evaluation Visit (18 months), Yearly Evaluation Visit (24 months)

• Percentage of Participants With Absence Seizure Freedom Based on Daily Seizure Diary Over the Entire Evaluation Period and by 3-month Time Intervals

  Months 1-3, Months 4-6, Months 7-9, Months 10-12, Months 13-15, Months 16-18, Months 19-21, Months 22-24 and Entire Evaluation Period (Up to 24 months)

Study Arms (1)

Brivaracetam arm

EXPERIMENTAL

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

Drug: Brivaracetam Film-coated tablet; Drug: Brivaracetam oral solution

Interventions

Brivaracetam Film-coated tablet DRUG

* 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.

Brivaracetam arm

Brivaracetam oral solution DRUG

* Pharmaceutical form: Oral solution * Route of administration: Oral use Brivaracetam oral solution \[10 mg/mL\]) will be administered twice per day in equal doses.

Brivaracetam arm

Eligibility Criteria

• Age: 2 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

Study Sites (24)

Ep0132 115

Birmingham, Alabama, 35233, United States

Location

Ep0132 105

Orange, California, 92868-3874, United States

Location

Ep0132 110

Augusta, Georgia, 30912, United States

Location

Ep0132 100

New Brunswick, New Jersey, 08901, United States

Location

Ep0132 109

Winston-Salem, North Carolina, 27157, United States

Location

Ep0132 400

Tbilisi, Georgia

Location

Ep0132 401

Tbilisi, Georgia

Location

Ep0132 402

Tbilisi, Georgia

Location

Ep0132 403

Tbilisi, Georgia

Location

Ep0132 405

Tbilisi, Georgia

Location

Ep0132 323

Messina, Italy

Location

Ep0132 321

Milan, Italy

Location

Ep0132 320

Pavia, Italy

Location

Ep0132 322

Roma, Italy

Location

Ep0132 325

Roma, Italy

Location

Ep0132 326

Verona, Italy

Location

Ep0132 562

Bucharest, Romania

Location

Ep0132 560

Iași, Romania

Location

Ep0132 561

Timişoara, Judeţ Timiş, Romania

Location

Ep0132 632

Bardejov, Slovakia

Location

Ep0132 630

Dubnica nad Váhom, Slovakia

Location

Ep0132 600

Dnipro, Ukraine

Location

Ep0132 601

Dnipro, Ukraine

Location

Ep0132 607

Uzhhorod, Ukraine

Location

MeSH Terms

Conditions

Epilepsy, Absence; Epilepsy

Interventions

brivaracetam

Condition Hierarchy (Ancestors)

Epilepsy, Generalized; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes

Limitations and Caveats

EP0132 enrolled fewer participants than expected (approximately 140) so it was closed prematurely, followed by the initiation of the managed access program EP0225 (NCTID not applicable) and its replacement with the new open-label study EP0224 (NCT06315322).

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 25, 2021
• First Posted: November 5, 2021
• Study Start: March 30, 2022
• Primary Completion: March 18, 2025
• Study Completion: March 18, 2025
• Last Updated: October 22, 2025
• Results First Posted: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (5); RO (3); IT (6); SL (2); GE (5); UA (3)