At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 144 enrolled
Drug / intervention
Zonisamidedrug
Likely dose
Zonisamide 8 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.
An Open-label Extension Study Following a Double-blind, Randomized, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Pediatric Partial Onset Seizures
In Brief
A Phase 3 clinical trial evaluating Zonisamide for Partial Seizures. Completed, enrolled 144 participants across 1 site.
Detailed Summary
The purpose of this study is to assess the long-term safety and efficacy of zonisamide used as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic drugs (AEDs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPartial Seizures
CountriesItaly
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedJun 2010
Primary CompletionJan 2012
Study CompletionMar 2012
TodayJul 2026
First PostedJun 4, 2010
Enrollment StartJul 1, 2008
Primary CompletionJan 1, 2012
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 16.1 years ago
Interventions
Zonisamidedrug
Transition Period from Study E2090-E044-312: Placebo Open-Label Period: 1 to 8 mg/kg orally per day for approximately 59 weeks.