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

NCT ID: NCT05109234

Last Updated: 2025-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-30
• Study Completion Date: 2025-03-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brivaracetam arm

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

Group Type: EXPERIMENTAL

Brivaracetam Film-coated tablet

Intervention Type: 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 oral solution

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Biopharma SRL

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

Ep0132 115

Birmingham, Alabama, United States

Ep0132 105

Orange, California, United States

Ep0132 110

Augusta, Georgia, United States

Ep0132 100

New Brunswick, New Jersey, United States

Ep0132 109

Winston-Salem, North Carolina, United States

Ep0132 400

Tbilisi, , Georgia

Ep0132 401

Tbilisi, , Georgia

Ep0132 402

Tbilisi, , Georgia

Ep0132 403

Tbilisi, , Georgia

Ep0132 405

Tbilisi, , Georgia

Ep0132 323

Messina, , Italy

Ep0132 321

Milan, , Italy

Ep0132 320

Pavia, , Italy

Ep0132 322

Roma, , Italy

Ep0132 325

Roma, , Italy

Ep0132 326

Verona, , Italy

Ep0132 562

Bucharest, , Romania

Ep0132 560

Iași, , Romania

Ep0132 561

Timişoara, Judeţ Timiş, , Romania

Ep0132 632

Bardejov, , Slovakia

Ep0132 630

Dubnica nad Váhom, , Slovakia

Ep0132 600

Dnipro, , Ukraine

Ep0132 601

Dnipro, , Ukraine

Ep0132 607

Uzhhorod, , Ukraine

Countries

United States; Georgia; Italy; Romania; Slovakia; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-002769-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EP0132

Identifier Type: -

Identifier Source: org_study_id