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

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: Zonisamide; Drug: Lamotrigine

• Registration Number: NCT00292461
• Lead Sponsor: Eisai Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-14
• Study First Submitted QC: 2006-02-14
• Study First Posted: 2006-02-16
• Study Start: 2006-03
• Status Verified: 2009-08
• Primary Completion: 2009-08
• Study Completion: 2009-09
• Results First Submitted: 2010-09-27
• Results First Submitted QC: 2011-07-20
• Results First Posted: 2011-08-15
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
zonisamide	Zonisamide	tablet
lamotrigine	Lamotrigine	tablet

Primary Outcome Measures

Name	Time	Method
The Percentage Change of Monthly Seizure Frequency at the End of the 16-week Treatment From Baseline	Baseline and 16 weeks	Percentage Change of Frequency = (T-B)/B\*100% T= Total seizure frequency during maintenance dose period / maintenance dose period (weeks)\* 4 B= The monthly seizure frequence with one month prior to enrollment

Secondary Outcome Measures

Name	Time	Method
Global Assessment of Efficacy by Physician at the End of 16-week Treatment Period	Baseline and 16 weeks
Global Assessment of Efficacy by Participants at the End of the 16-week Treatment Period	Baseline and 16 weeks
Response Rate: Defined as the Percentage of Participants With >= 50% Reduction of Monthly Seizure Frequency at the End of 16-week Treatment From Baseline.	Baseline and 16 weeks

Trial Locations

Locations (6)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan, China

Chang-Gung Memorial Hospital (CGMH); 🇨🇳 Taipei, Taiwan, China

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan, China

China Medical University Hospital (CMUH); 🇨🇳 Taichun, Taiwan, China

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan, China

Taipei Tzu Chi General Hospital; 🇨🇳 Taipei, Taiwan, China