CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 63 enrolled
Drug / intervention
Topiramate +1 moredrug
Likely dose
Topiramate 350 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.

Search/NCT02201251
NCT02201251Phase 3Completed
CompareCT.gov

A Randomized, Active-Controlled, Open-Label, Flexible-Dose Study to Assess the Safety and Tolerability of Topiramate as Monotherapy Compared With Levetiracetam as Monotherapy in Pediatric Subjects With New or Recent-Onset Epilepsy

Janssen Research & Development, LLC·interventional·Posted Jul 28, 2014·Updated Apr 29, 2025

In Brief

A Phase 3 clinical trial evaluating Topiramate and Levetiracetam for Epilepsy. Completed, enrolled 63 participants across 41 sites in 14 countries.

Detailed Summary

The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone formation in children aged 2 to 15 years.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesArgentina, Australia, Austria, Belgium, Canada, France, Germany, Hungary, Philippines, Poland, Russia, South Africa, Taiwan, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 28, 2014
Enrollment StartOct 6, 2014
Primary CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 11.9 years ago

Interventions

Topiramatedrug

Topiramate weight based dosing for participants 2 to \<10 years of age not to exceed 350 mg/day, as tolerated; not to exceed 400 mg/day in participants 10-15 years of age, as tolerated.

Levetiracetamdrug

Levetiracetam weight based dosing for all participants 2-15 years of age, not to exceed 60 mg/kg/day, as tolerated. The maximum recommended daily dosage is 3,000 mg.