At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 71 enrolled
Drug / intervention
Levetiracetam (LEV)drug
Likely dose
Levetiracetam (LEV) 250 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.
An Open-label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Levetiracetam Used as Monotherapy in Newly or Recently Diagnosed Epilepsy Patients Aged Older Than or Equal to 16 Years With Partial Seizures
In Brief
A Phase 3 clinical trial evaluating Levetiracetam (LEV) for Epilepsy and Partial Onset Seizures. Completed, enrolled 71 participants across 27 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Partial Onset Seizures
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2011
First PostedJan 2012
Primary CompletionOct 2013
Study CompletionApr 2015
TodayJul 2026
First PostedJan 10, 2012
Enrollment StartDec 1, 2011
Primary CompletionOct 1, 2013
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.5 years ago
Interventions
Levetiracetam (LEV)drug
* Active Substance: Levetiracetam * Pharmaceutical Form: Film-coated tablet * Concentration: LEV 250 mg, LEV 500 mg * Frequency: Twice daily * Route of Administration: Oral use