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Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy

Open-label, Single-arm, Multicenter, Long-term Study to Evaluate Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects With Epilepsy

NCT01364597•UCB Pharma SA

View on ClinicalTrials.gov

Summary

This study will evaluate the safety and tolerability of brivaracetam in pediatric subjects with epilepsy.

Detailed Description

This is a Phase 3, open-label, single-arm, multicenter, long-term study to evaluate the safety and efficacy of brivaracetam (BRV) in children with epilepsy. This study was initially designed for pediatric subjects who had completed a previous BRV study. With protocol amendment 4, enrollment for "directly enrolled" subjects was modified from 'up to' an additional 100 subjects to "at least" 100 subjects, keeping the planned total enrollment of approximately 600 subjects to allow flexibility in the number of patients reaching 1 year of exposure. With protocol amendment 5, entry criteria for subjects coming for other pediatric core studies in development were included. Additional clarity was provided for subjects enrolled in N01266 that temporary roll over to one of those studies and resume participation in N01266. With protocol amendment 6, central EEG reading and entry visit EEG were removed. Some clarifications on study assessments (questionnaires, EEGs) was provided and inclusion criteria were aligned from an earlier local amendment. With protocol amendment 7, the pregnancy section was updated to clarify that Pregnancy Report and Outcome Form has to be completed in all pregnancies. With protocol amendment 8, re-categorization of study variables in compliance with reporting registries was performed. Modifications due to COVID19 pandemic were implemented and clarification provided that participants may transition to another BRV study. The primary objective is to evaluate the long-term safety and tolerability of BRV. The secondary objective is to assess the efficacy of BRV during long-term exposure.

Eligibility

Age

0 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All Subjects:
•Informed Consent form (ICF) is signed and dated by the parent(s) or legal representative(s)
•Subject/legal representative is considered reliable and capable of adhering to the protocol
•For female subjects:
•Subject is not of childbearing potential
•OR if women of childbearing potential, and sexually active only if:
•Adequate Contraceptive method
•Negative pregnancy test
•Understands the consequences and potential risks of inadequately protected sexual activity, understands and properly uses contraceptive methods, and is willing to inform the Investigator of any contraception changes
•Long Term Follow-up Subjects:
+8 more criteria

Exclusion Criteria

•All Subjects:
•Subject is a pregnant or nursing female
•Subject has severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the subject.
•Subject has planned participation in any clinical study of another investigational drug or device.
•Subject has \>1.5x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or \>1.0xULN total bilirubin (≥1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are \>ULN and \<1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin \<35%). N01349 subjects with a total bilirubin \> ULN may be considered for the study if benign unconjugated hyperbilirubinemia is suspected in the context of prolonged neonatal jaundice, after discussion with the medical monitor. For randomized subjects with a baseline result \>ULN for ALT, AST, ALP, or total bilirubin, a baseline diagnosis and/or the cause of any clinically meaningful elevation must be understood and recorded in the eCRF. If subject has \>ULN ALT, AST, or ALP that does not meet the exclusion limit at the baseline referenced in Table 5-1 for LTFU subjects and at the Screening Visit for directly enrolled subjects, repeat the tests, if possible, prior to dosing to ensure there is no further ongoing clinically relevant increase. In case of a clinically relevant increase, inclusion of the subject must be discussed with the Medical Monitor. Tests that result in ALT, AST, or ALP up to 25% above the exclusion limit may be repeated once for confirmation. This includes re-screening.
•Subject has chronic liver disease.
•Long Term Follow-up Subjects:
•Subject had hypersensitivity to BRV or excipients or comparative drugs as stated in this protocol during the course of the core study.
•Subject had poor compliance with the visit schedule or medication intake in the core study.
•Subject ≥6 years of age has a lifetime history of suicide attempt (including actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the EV. If a subject has active suicidal ideation without a specific plan as indicated by a positive response ("Yes") to Question 4 of Columbia-Suicide Severity Rating Scale (C SSRS) at the EV, the subject should be referred immediately to a Mental Healthcare Professional and may be excluded from the study based upon the Investigator's judgment of benefit/risk of continuing the subject in the study/on study medication.
+19 more criteria

Locations (56)

N01266 243

Los Angeles, California, United States

N01266 108

Gulf Breeze, Florida, United States

N01266 103

Wellington, Florida, United States

N01266 118

Chicago, Illinois, United States

N01266 106

Boston, Massachusetts, United States

N01266 101

Saint Paul, Minnesota, United States

N01266 113

Chesterfield, Missouri, United States

N01266 105

Buffalo, New York, United States

N01266 252

New York, New York, United States

N01266 104

Rochester, New York, United States

Key Dates

Start Date

August 1, 2011

Primary Completion Date

February 3, 2022

Completion Date

February 3, 2022

Last Updated

October 20, 2025

Enrollment

257

ACTUAL participants

Conditions

Epilepsy

Interventions

Brivaracetam (BRV)

DRUG

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Epilepsy; Seizure

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RECRUITINGPHASE1

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NCT02531880

Epilepsy

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Open-label Long-term Study of Adjunctive Brivaracetam in Pediatric Subjects With Epilepsy

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

Late-Onset Seizures: Trial of Vascular Risk Investigation and Treatment

AI-Based Mobile Intervention on Medication Non-Adherence and Transition

MEHMO Natural History and Biomarkers