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

September 1, 2009 updated by: Eisai Korea Inc.
To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  1. Patients over 13 years old (complete the elementary school course).
  2. Patients had at least two seizures in the past and at least one seizure for the last 3 months before screening.
  3. Patients had no antiepileptic drugs for the last 4 months.
  4. Women of childbearing age who agree to contraception during participating this clinical trial.

Exclusion criteria:

  1. Pregnancy
  2. Patients who have progressive neurologic disease
  3. Allergy to sulfonamides
  4. Use of acetazolamide within a year
  5. Hemolytic anemia
  6. Patients who have abnormal liver function (GOT or GPT) values more than twice the normal values.
  7. Patients who have abnormal renal function (BUN or Creatinine) values more than three times the normal values.
  8. Patients who have history of drug or alcohol abuse.
  9. Glucose-6-phosphate dehydrogenase deficiency.
  10. Patients who were detected with renal stones on KUB (Kidney-Ureter-Bladder) test.
  11. Patients who have progressive internal or surgical disease.
  12. Patients who have progressive psychiatric disease.
  13. Patients who have mental retardation (IQ 70 and less).
  14. Patients taking Vit C.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Zonisamide
Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.
Other Names:
  • Zonegran
Active Comparator: 2
Drug: Topiramate
Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Seizure frequency
Time Frame: 2, 4, 8, 12, 16, 20, 24 weeks
2, 4, 8, 12, 16, 20, 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cognitive function
Time Frame: 0, 24 weeks
0, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Korea Inc.

Investigators

  • Study Director: Jihee Mun, Eisai Korea Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

September 2, 2009

Last Update Submitted That Met QC Criteria

September 1, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2090-S082-403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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