At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 125 enrolled
Drug / intervention
zonisamide low dose group +1 moredrug
Likely dose
zonisamide low dose group 2mg/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 Multi-center Comparative Trial of Low and High Dose Zonisamide in Children as Monotherapy
In Brief
A Phase 4 clinical trial evaluating zonisamide low dose group and zonisamide high dose group for Epilepsy. Completed, enrolled 125 participants across 11 sites.
Detailed Summary
The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesSouth Korea
Collaborators--
Timeline
Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
Primary CompletionMar 2009
Study CompletionJul 2009
First PostedMay 2010
TodayJul 2026
First PostedMay 20, 2010
Enrollment StartMar 1, 2006
Primary CompletionMar 1, 2009
Study CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 16.1 years ago
Interventions
zonisamide low dose groupdrug
Initial dose was 2mg/kg/day, increased after 1\~2 weeks to 3\~4mg/kg/day.
zonisamide high dose groupdrug
Initial dose was 2mg/kg/day, increased after 2\~4 weeks to 6\~8mg/kg/day.