drugset / Trial / NCT00419094

Conversion to Monotherapy Study With Keppra XR for Partial Seizures

NCT00419094 ↗

Phase 3 Completed 228 enrolled UCB Pharma
RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.

Timeline

Start
2007-08
Primary completion
2009-09
Completion
2009-09

Outcome

Met primary endpoint

paper The cumulative exit rate for patients on LEV XR 2000 mg/day (0.375 [95% CI 0.297, 0.453]) was significantly lower than historical control (0.653). PMID 22516508 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Keppra XR Unknown 1000 mg —
Subject Keppra XR Unknown 2000 mg —

Indications