CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 13 enrolled
Drug / intervention
Levetiracetamdrug
Likely dose
Levetiracetam 20 mg/kgfrom 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.

Search/NCT01292837
NCT01292837Phase 3Completed
CompareCT.gov

An Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Adjunctive Treatment With Levetiracetam in Japanese Patients (≥4 to <16 Years) With Uncontrolled Generalized Tonic-clonic (GTC) Seizures Despite Treatment With 1 or 2 Antiepileptic Drug(s)

UCB Japan Co. Ltd.·interventional·Posted Feb 10, 2011·Updated May 15, 2015

In Brief

A Phase 3 clinical trial evaluating Levetiracetam for Epilepsy and Generalized Tonic-clonic Seizures. Completed, enrolled 13 participants across 26 sites.

Detailed Summary

To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to \<16 years with uncontrolled Generalized Tonic-Clonic (GTC) seizures despite treatment with 1 or 2 Anti-Epileptic Drugs (AEDs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Generalized Tonic-clonic Seizures
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2011
Enrollment StartFeb 1, 2011
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.4 years ago

Interventions

Levetiracetamdrug

The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.