A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

Description

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Conditions

Epilepsy

Study Overview

Study Details

Study overview

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy

A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

Condition
Epilepsy
Intervention / Treatment

-

Contacts and Locations

Hawthorne

Ep0156 259, Hawthorne, New York, United States, 10532

Durham

Ep0156 237, Durham, North Carolina, United States, 27710

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\]
  • * Study participant is ≥ 4 years to \< 16 years of age
  • * Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
  • * Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)
  • * Study participant had at least 1 POS during the 4-week Screening Period
  • * Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
  • * Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).
  • * Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
  • * Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period
  • * Study participant has any clinically significant illness
  • * Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
  • * Study participant has a clinically significant ECG abnormality
  • * Study participant had major surgery within 6 months prior to the ScrV

Ages Eligible for Study

1 Month to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

UCB Biopharma SRL,

UCB Cares, STUDY_DIRECTOR, 001 844 599 2273 (UCB)

Study Record Dates

2029-07-17