A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR

Summary

This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.

Timeline

Start

2006-08

Primary completion

2007-05

Completion

2007-05

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Keppra®: 0.912 (Standard Error 0.053) seizures per week (log-transformed data) NCT00368069 ↗

registry analysis (unspecified test); Keppra® vs Placebo; p = 0.038; Mean Difference (Net) 0.155 (95% CI 0.009 to 0.301); ANCOVA NCT00368069 ↗

registry LEAST_SQUARES_MEAN Keppra®: 0.914 (Standard Error 0.049) seizures per week (log-transformed data) NCT00368069 ↗

registry analysis (unspecified test); Keppra® vs Placebo; p = 0.003; Mean Difference (Net) 0.205 (95% CI 0.070 to 0.341); ANCOVA NCT00368069 ↗

Publications

• Results Peltola J, Coetzee C, Jimenez F, Litovchenko T, Ramaratnam S, Zaslavaskiy L, Lu ZS, Sykes DM; Levetiracetam XR N01235 Study Group. Once-daily extended-release levetiracetam as adjunctive treatment of partial-onset seizures in patients with epilepsy: a double-blind, randomized, placebo-controlled trial. Epilepsia. 2009 Mar;50(3):406-14. doi: 10.1111/j.1528-1167.2008.01817.x.
• Results Richy FF, Banerjee S, Brabant Y, Helmers S. Levetiracetam extended release and levetiracetam immediate release as adjunctive treatment for partial-onset seizures: an indirect comparison of treatment-emergent adverse events using meta-analytic techniques. Epilepsy Behav. 2009 Oct;16(2):240-5. doi: 10.1016/j.yebeh.2009.07.013. Epub 2009 Aug 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Levetiracetam	Other / unclassified	1000 mg	Oral

Indications