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Completed

NCT Number: NCT00154076

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

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Daegu Catholic University Medical Center

Daegu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

zonisamide

Drug

Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.

Other names: Zonegran

Topiramate

Drug

Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.

Primary outcomes

  1. Seizure frequency

    Time frame: 2, 4, 8, 12, 16, 20, 24 weeks

Secondary outcomes

  1. Cognitive function

    Time frame: 0, 24 weeks

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Sep 12, 2005
Registry last updated
Sep 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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