At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 361 enrolled
Drug / intervention
Levetiracetam +1 moredrug
Likely dose
Levetiracetam 1000 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 Double-blind, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Oral Levetiracetam, in Epilepsy Patients Aged ≥16 Years, With Generalized Tonic-clonic (GTC) Seizures
In Brief
A Phase 3 clinical trial evaluating Levetiracetam and Placebo for Epilepsy and Generalized Tonic-Clonic Seizures. Completed, enrolled 361 participants across 58 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of levetiracetam treatment used as adjunctive therapy in Japanese and Chinese epilepsy patients aged ≥16 years and with uncontrolled Generalized Tonic-Clonic seizures despite treatment with 1 or 2 anti-epileptic drugs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Generalized Tonic-Clonic Seizures
CountriesChina, Japan
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2010
First PostedOct 2010
Primary CompletionApr 2014
Study CompletionMay 2014
TodayJul 2026
First PostedOct 26, 2010
Enrollment StartOct 1, 2010
Primary CompletionApr 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 15.7 years ago
Interventions
Levetiracetamdrug
Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks
Placebodrug
Matching oral placebo tablets twice daily for 28 weeks