At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 158 enrolled
Drug / intervention
Keppra® extended release formulation - XR +1 moredrug
Likely dose
Keppra XR 1000 mg orally once daily (500 mg extended release tablet, 2 tablets once daily)AI-extracted
Key inclusion· 4
- ✓Confirmed diagnosis of refractory epilepsy
- ✓Age 12 to 70 years
- ✓Receiving stable dose of 1–3 concomitant anti-epileptic drugs (AED)
- ✓Partial onset seizures
Key exclusion· 5
- ✕Seizures occurring in clusters
- ✕Status epilepticus within 3 months of Visit 1
- ✕History of non-epileptic seizures
- ✕Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.
In Brief
A Phase 3 clinical trial evaluating Keppra® extended release formulation - XR and Placebo for Epilepsy. Completed, enrolled 158 participants across 34 sites in 7 countries.
Detailed Summary
This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesBrazil, Finland, India, Mexico, Russia, South Africa, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2006
First PostedAug 2006
Primary CompletionMay 2007
TodayJul 2026
First PostedAug 24, 2006
Enrollment StartAug 1, 2006
Primary CompletionMay 1, 2007
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.9 years ago
Interventions
Keppra® extended release formulation - XRdrug
500mg extended release oral tablet, 2 tablets once daily
Placebodrug
oral tablets, 2 tablets once daily