Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

Phase 4

Completed

• Conditions: Epilepsy
• Interventions: Drug: zonisamide

• Registration Number: NCT01140867
• Lead Sponsor: Eisai Korea Inc.

Brief Summary

The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.

Detailed Description

The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 \~ 400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures \[SPS\], complex partial seizures \[CPS\], simple partial seizures evolving into generalized tonic-clonic convulsions \[SGTC\] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment.

Study Timeline

• Study Start: 2008-02-29
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-10
• Primary Completion: 2010-08-31
• Study Completion: 2011-03-31
• Status Verified: 2011-05
• Results First Submitted: 2011-08-05
• Results First Submitted QC: 2011-08-05
• Results First Posted: 2011-09-08
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	zonisamide	-

Primary Outcome Measures

Name	Time	Method
Seizure Reduction Rate	Baseline and 16 weeks	The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.

Secondary Outcome Measures

Name	Time	Method
Seizure Free Rate	16 weeks	The percentage of the participants who experienced no seizure during the trial.
Responder Rate	Baseline and 16 weeks	The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.
QoL-QOLIE31 (Quality of Life in Epilepsy)	Baseline and 16 weeks	Quality of life assessment tool. Overall scores is calculated by summing subsections, and it ranges from 0 to 100. Higher score presents higher quality of life.

Trial Locations

Locations (10)

Kangdong Sacred Heart Hosp., Dept. of Neurology; 🇰🇷 Seoul, Korea, Republic of

Bundang CHA Hospital, Dept. of Neurology; 🇰🇷 Seongnam, Korea, Republic of

Dong-A University Hospital, Dept. of Neurology; 🇰🇷 Busan, Korea, Republic of

Keimyung Univ.Dongsan Medical Centre, Dept. of Neurology; 🇰🇷 Daegu, Korea, Republic of

Inje Univ. Pusan Paik Hospital, Dept. of Neurology; 🇰🇷 Busan, Korea, Republic of

Gachon Medical School Gil Medical Centre, Dept.of Neurology; 🇰🇷 Incheon, Korea, Republic of

Yeungnam Univ. Medical Center, Dept. of Neurology; 🇰🇷 Daegu, Korea, Republic of

Severance Hospital, Dept. of Neurology; 🇰🇷 Seoul, Korea, Republic of

Natl. Health Insurance Corporation Ilsan Hosp., Dept. of Neurology; 🇰🇷 Koyang, Korea, Republic of

Kyungpook Natl. Univ. Hosp., Dept. of Neurology; 🇰🇷 Daegu, Korea, Republic of