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

A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

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

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: zonisamide

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong-A University Hospital, Dept. of Neurology
  • Busan, Korea, Republic of
    • Inje Univ. Pusan Paik Hospital, Dept. of Neurology
  • Daegu, Korea, Republic of
    • Keimyung Univ.Dongsan Medical Centre, Dept. of Neurology
  • Daegu, Korea, Republic of
    • Kyungpook Natl. Univ. Hosp., Dept. of Neurology
  • Daegu, Korea, Republic of
    • Yeungnam Univ. Medical Center, Dept. of Neurology
  • Incheon, Korea, Republic of
    • Gachon Medical School Gil Medical Centre, Dept.of Neurology
  • Koyang, Korea, Republic of
    • Natl. Health Insurance Corporation Ilsan Hosp., Dept. of Neurology
  • Seongnam, Korea, Republic of
    • Bundang CHA Hospital, Dept. of Neurology
  • Seoul, Korea, Republic of
    • Kangdong Sacred Heart Hosp., Dept. of Neurology
  • Seoul, Korea, Republic of
    • Severance Hospital, Dept. of Neurology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Epilepsy patient over 15 years old who agrees with Informed Consent Form
2. Patient who has classifiable uncontrolled partial epilepsy according to International Classification of Epileptic Seizures.
3. Patient who has 3 ~ dozens of partial seizure (average more than once seizure per 4 weeks) last 12 weeks despite taking 1 ~ 3 antiepileptic drug(s).
4. Patient who takes 1 ~ 3 marketed antiepileptic drug(s) excluding zonisamide at point of enrollment time.
5. Before study visit, patient who takes stable dose of antiepileptic drug more than 4 weeks.

Exclusion criteria:

1. Patient who has progressive central nervous system (CNS) disorder and/or degenerative disease of the brain.
2. Patient who experiences pseudoseizures and/or who has uncountable clusters.
3. Patient who has serious systemic or drug metabolism affecting disorder .
4. Upward of doubled normal glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), bilirubin, blood urea nitrogen (BUN), creatinine levels.
5. Patient who has absolute neutrophil counts <1800/mm3 or platelets <100,000/mm3.
6. Patient who has medical history of renal stones.
7. Patient who is allergic to sulfonamide.
8. Medical history of medicinal poisoning and/or alcoholism and/or serious psychological disorder.
9. Pregnant women, lactating women, women of childbearing age who do not use a preventive method of conception.
10. A terminal patient and/or a scheduled surgical patient.
11. Patient who has medication history of zonisamide.
12. Patient who participated other clinical trial within the last 12 weeks at point of enrollment time of this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: zonisamide; zonisamide 100 mg tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure Reduction Rate	The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.	Baseline and 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure Free Rate	The percentage of the participants who experienced no seizure during the trial.	16 weeks
Responder Rate	The percentage of participants whose median percentage change in seizure frequency after Zonisamide treatment is reduced over 50%.	Baseline and 16 weeks
QoL-QOLIE31 (Quality of Life in Epilepsy)	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.	Baseline and 16 weeks

Collaborators and Investigators

• Sponsor: Eisai Korea Inc.
• Investigators: Study Director: Jihee Mun, Medical Department, Eisai Korea Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2008
• Primary Completion (Actual): August 31, 2010
• Study Completion (Actual): March 31, 2011

Study Registration Dates

• First Submitted: May 19, 2010
• First Submitted That Met QC Criteria: June 8, 2010
• First Posted (Estimate): June 10, 2010

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Zonisamide
• Other Study ID Numbers: E2090-S082-409