At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 228 enrolled
Drug / intervention
Keppra XR +1 moredrug
Likely dose
Keppra XR 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures
In Brief
A Phase 3 clinical trial evaluating Keppra XR for Epilepsy. Completed, enrolled 228 participants across 45 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesMexico, Poland, Russia, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 2007
Enrollment StartAug 2007
Primary CompletionSep 2009
TodayJul 2026
First PostedJan 8, 2007
Enrollment StartAug 1, 2007
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.5 years ago
Interventions
Keppra XRdrug
Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks
Keppra XRdrug
Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks