A Double-blind, Randomized Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures

Summary

Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy

Timeline

Start

2008-08

Primary completion

2010-01

Completion

2010-02

Outcome

Met primary endpoint

Stopped: “An interim analysis revealed the study was unlikely to attain a positive outcome for the efficacy analysis. No safety concerns were detected.”

paper In both studies, the cumulative exit rate was lower than the historical control threshold (N01276: 0.487, 95% CI 0.347, 0.626; PMID 29486396 ↗

Publications

• Results Arnold S, Badalamenti V, Diaz A, Gasalla T, McShea C, Whitesides J, Fakhoury T. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: Two double-blind, randomized, multicenter, historical control, Phase III studies. Epilepsy Res. 2018 Mar;141:73-82. doi: 10.1016/j.eplepsyres.2018.02.005. Epub 2018 Feb 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brivaracetam	Small molecule	50 mg	—
Subject	Brivaracetam	Small molecule	100 mg	—

Indications