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A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Zonisamide
Topiramate
Sponsored by
Eisai Korea Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: Patients over 13 years old (complete the elementary school course). Patients had at least two seizures in the past and at least one seizure for the last 3 months before screening. Patients had no antiepileptic drugs for the last 4 months. Women of childbearing age who agree to contraception during participating this clinical trial. Exclusion criteria: Pregnancy Patients who have progressive neurologic disease Allergy to sulfonamides Use of acetazolamide within a year Hemolytic anemia Patients who have abnormal liver function (GOT or GPT) values more than twice the normal values. Patients who have abnormal renal function (BUN or Creatinine) values more than three times the normal values. Patients who have history of drug or alcohol abuse. Glucose-6-phosphate dehydrogenase deficiency. Patients who were detected with renal stones on KUB (Kidney-Ureter-Bladder) test. Patients who have progressive internal or surgical disease. Patients who have progressive psychiatric disease. Patients who have mental retardation (IQ 70 and less). Patients taking Vit C.

Sites / Locations

  • Daegu Catholic University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Seizure frequency

Secondary Outcome Measures

Cognitive function

Full Information

First Posted
September 8, 2005
Last Updated
September 1, 2009
Sponsor
Eisai Korea Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00154076
Brief Title
A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Korea Inc.

4. Oversight

5. Study Description

Brief Summary
To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Zonisamide
Other Intervention Name(s)
Zonegran
Intervention Description
Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.
Intervention Type
Drug
Intervention Name(s)
Topiramate
Intervention Description
Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.
Primary Outcome Measure Information:
Title
Seizure frequency
Time Frame
2, 4, 8, 12, 16, 20, 24 weeks
Secondary Outcome Measure Information:
Title
Cognitive function
Time Frame
0, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Patients over 13 years old (complete the elementary school course). Patients had at least two seizures in the past and at least one seizure for the last 3 months before screening. Patients had no antiepileptic drugs for the last 4 months. Women of childbearing age who agree to contraception during participating this clinical trial. Exclusion criteria: Pregnancy Patients who have progressive neurologic disease Allergy to sulfonamides Use of acetazolamide within a year Hemolytic anemia Patients who have abnormal liver function (GOT or GPT) values more than twice the normal values. Patients who have abnormal renal function (BUN or Creatinine) values more than three times the normal values. Patients who have history of drug or alcohol abuse. Glucose-6-phosphate dehydrogenase deficiency. Patients who were detected with renal stones on KUB (Kidney-Ureter-Bladder) test. Patients who have progressive internal or surgical disease. Patients who have progressive psychiatric disease. Patients who have mental retardation (IQ 70 and less). Patients taking Vit C.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihee Mun
Organizational Affiliation
Eisai Korea Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

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