Journal article
Brivaracetam as adjunctive treatment for uncontrolled partial epilepsy in adults: A phase III randomized, double-blind, placebo-controlled trial
V Biton, SF Berkovic, B Abou-Khalil, MR Sperling, ME Johnson, S Lu
Epilepsia | Published : 2014
DOI: 10.1111/epi.12433
Open access
Abstract
Purpose Brivaracetam (BRV) is a novel high-affinity synaptic vesicle protein 2A ligand currently being investigated for the treatment of epilepsy. The purpose of this phase III study was to evaluate the efficacy and safety/tolerability of adjunctive BRV in adults with uncontrolled partial-onset (focal) seizures. Methods This was a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose trial (N01253; NCT00464269). Adults aged 16-70 years with well-characterized partial epilepsy not fully controlled despite treatment with one or two antiepileptic drugs (AEDs) were enrolled. Patients who experienced eight or more partial-onset seizures, whether or not..
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Funding Acknowledgements
This study was sponsored by UCB Pharma. UCB Pharma was involved in the design and conduct of the study, and collection, management, and analysis of the data. The authors thank the members of the N01253 Study Group and the patients who participated in the study for their contribution to the research; Laurent Turet, PhD (UCB Pharma), for critical review and coordination of the manuscript preparation; and David Sen, PhD (UCB Pharma), for providing statistical input. Sally Cotterill, PhD (QXV Communications, Macclesfield, United Kingdom) provided writing support, which was funded by UCB Pharma.