At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 398 enrolled
Drug / intervention
Levetiracetamdrug
Likely dose
Levetiracetam 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 Multicenter, Open, Long-term Follow-up Study to Evaluate the Safety and Efficacy of L059 (Levetiracetam) at Individual Optimal Dose Ranging From 500 to 3000 mg/Day in Twice Daily Administration in Subjects From 16 to 65 Years With Epilepsy Suffering From Partial Onset Seizures Whether or Not Secondarily Generalized Who Completed in a Previous Study
In Brief
A Phase 3 clinical trial evaluating Levetiracetam for Epilepsies and Partial. Completed, enrolled 398 participants across 53 sites.
Detailed Summary
This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in long-term administration in patients who completed N01020 \[NCT00160165\] or N01221 \[NCT00280696\].
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsies, Partial
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2006
First PostedAug 2006
Primary CompletionDec 2010
TodayJul 2026
First PostedAug 22, 2006
Enrollment StartJul 1, 2006
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 19.9 years ago
Interventions
Levetiracetamdrug
Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).