A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Phase 3 Active not recruiting 153 enrolled UCB Biopharma SRL

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

Timeline

Start: 2021-07-29
Primary completion: 2026-08-24
Completion: 2026-08-24

Publications

Results Bast T, Schulz AL, Floricel F, Morita D, Cleveland JM, Elshoff JP. Efficacy and tolerability of brivaracetam monotherapy in childhood and juvenile absence epilepsy: An innovative adaptive trial design. Epilepsia Open. 2022 Dec;7(4):588-597. doi: 10.1002/epi4.12628. Epub 2022 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brivaracetam	Small molecule	100 mg	Oral
Subject	Brivaracetam	Small molecule	200 mg	Oral

A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Summary

Timeline

Publications

Drugs

Indications