CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 73 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/NCT01063764
NCT01063764Phase 3Completed
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An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2 Anti-Epileptic Drugs

UCB Japan Co. Ltd.·interventional·Posted Feb 5, 2010·Updated Mar 5, 2015

In Brief

A Phase 3 clinical trial evaluating Levetiracetam for Epilepsy and Partial Seizures. Completed, enrolled 73 participants across 29 sites.

Detailed Summary

Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with 1 or 2 anti-epileptic drug(s).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Partial Seizures
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 5, 2010
Enrollment StartJan 1, 2010
Primary CompletionApr 1, 2011
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.4 years ago

Interventions

Levetiracetamdrug

First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks. Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.