Epilepsy Therapy Using Brivaracetam with Other Medications – Phase III

Study to Evaluate the Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Pediatric Subjects with Epilepsy

Protocol Description

This multicenter international study is an extension of a prior study in which the investigational drug brivaracetam was evaluated for safety, tolerability and effectiveness in treatment of pediatric patients with epilepsy. Studies using brivaracetam along with other anti-epileptic therapy in adults with epilepsy have shown promising results in both effectiveness and safety. This program extends the study period for up to 3 years.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting children, adolescents and teens of both genders, who have epilepsy with partial-onset seizures, who are already taking an antiepileptic drug (AED), and who participated in the prior qualifying study.
Males and Females: 4 to 17 years of age


Participants in this study will continue to receive their usual AED. Additionally, researchers will provide the study drug at the same dose level as taken at the last visit in the prior study, either as an oral solution or tablet, dependent on weight and age. Participants will visit the study doctor monthly for the first 3 months and thereafter every 3 months for up to 3 years. Patients and caregivers will need to maintain journals of seizure activity for review during study visits, which will include physical examinations and, at certain intervals, blood sampling, electroencephalograms, and other tests.
Visits: Up to 14
Duration: Up to 3 years

Status: Enrolling by Invitation

Source(s) of Support

UCB Pharma

Primary Investigator

Inna Ilana Vaisleib, MD

Contact Information

For more information about the study or enrollment, please contact:
Jennifer Monahan, Clinical Research Coordinator