At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 207 enrolled
Drug / intervention
Zonisamide +1 moredrug
Likely dose
Zonisamide 8mg/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.
A Double-blind, Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures
In Brief
A Phase 3 clinical trial evaluating Zonisamide and Placebo for Epilepsy; Paediatric Partial Onset Seizures. Completed, enrolled 207 participants across 43 sites in 9 countries.
Detailed Summary
The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Estonia, France, Hungary, Italy, Latvia, Poland, Spain, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 2007
Enrollment StartDec 2008
Primary CompletionMar 2011
TodayJul 2026
First PostedDec 3, 2007
Enrollment StartDec 1, 2008
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.6 years ago
Interventions
Zonisamidedrug
8mg/kg per day for approximately 24 weeks.
Placebodrug