CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 64 enrolled
Drug / intervention
Zonisamide +1 moredrug
Likely dose
Not stated in record
Key inclusion· 1
  • ✓Clinical diagnosis of refractory epilepsy
Key exclusion· 17
  • ✕Progressive neurologic disease
  • ✕Serious psychiatric disease
  • ✕Hemolytic anemia
  • ✕G6PD (glucose-6-phosphate dehydrogenase) deficiency

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00292461
NCT00292461Phase 3Completed
CompareCT.gov

A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures

Eisai Inc.·interventional·Posted Feb 16, 2006·Updated May 20, 2013

In Brief

A Phase 3 clinical trial evaluating Zonisamide and Lamotrigine for Epilepsy. Completed, enrolled 64 participants across 8 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of zonisamide for anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial or partial with secondary generalized seizures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 16, 2006
Enrollment StartMar 1, 2006
Primary CompletionAug 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 20.4 years ago

Interventions

Zonisamidedrug

Tablet once or twice daily orally for 16 weeks

Lamotriginedrug

Tablet once daily orally for 16 weeks