Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures

Phase 3

Completed

• Conditions: Partial Seizures
• Interventions: Drug: Placebo; Drug: Zonisamide

• Registration Number: NCT00327717
• Lead Sponsor: Eisai Inc.

Brief Summary

The objectives of this trial are to evaluate the safety and efficacy of Zonisamide as adjunctive therapy in medically refractory patients receiving other antiepileptic drugs (AEDs).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-17
• Study First Submitted QC: 2006-05-17
• Study First Posted: 2006-05-18
• Study Start: 2006-09
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2010-10-28
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-14
• Last Update Submitted: 2014-08-14
• Results First Posted: 2014-08-15
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Zonisamide 100 mg tablet	Zonisamide	-

Primary Outcome Measures

Name	Time	Method
Median Percent Change From Baseline in All Partial Seizure Frequency (Complex Partial Seizures (CP)+ Simple Partial Seizures (SP) + Secondary Generalization Seizures (SGS)) During the Fixed-dose Phase	Baseline and 16 weeks	The median percent change in seizure frequency of all partial seizures (CP+SP+SGS) from baseline during the fixed-dose phase.

Secondary Outcome Measures

Name	Time	Method
The Mean Percent Change From Baseline in Complex Partial (CP) Seizure Frequency	Baseline and 16 weeks	The Mean Percent Change in seizure frequency of CP from baseline during the fixed-dose phase.
The Mean Percent Change From Baseline in Simple Partial (SP) Seizure Frequency	Baseline and 16 weeks	The Mean percent change in seizure frequency of SP from baseline during the fixed-dose phase.
The Mean Percent Change From Baseline in Partial Seizures With Secondary Generalization (SGS)	Baseline and 16 weeks	The mean percent change in seizure frequency of SGS from baseline during the fixed-dose phase.
Responder Rate	Baseline and 16 weeks	Responder rate is defined as percentage of participants with \>=50% reduction in seizure frequency from baseline.
Mean Number of Seizure Free Days	12 weeks	Mean number of seizure free days per 28 day period during fixed dose phase
Mean Time to First Seizure (Days)	16 weeks	Mean time to first seizure during fixed dose phase
Percentage of Seizure-free Participants During Fixed-dose Phase	16 weeks	Percentage of seizure-free participants during fixed-dose phase
Drop - Out Rate	16 weeks	Number of Participants who dropped out of the study. In the Study drop-out rate is defined as number of participants.
Mean Percentage of Change in Seizure Free Days	16 weeks

Trial Locations

Locations (8)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China

Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Hua-shan Hospital; 🇨🇳 Shanghai, Shanghai, China

XiÆan Xijing Hospital; 🇨🇳 XiÆan, Shanxi, China

Chengdu Huaxi Hospital; 🇨🇳 Chengdu, Sichuan, China