Skip to main content
OpenTrials
Completed

NCT Number: NCT01127256

Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation

The purpose of this study is to compare the efficacy and safety of zonisamide with carbamazepine and to determine the optimum dose of zonisamide in patients with epilepsy.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National Univ. Bundang Hosp., Bundang, South Korea

Loading trial locations.

About this study

To compare efficacy and safety between the zonisamide group and the carbamazepine group. The zonisamide group will be divided into 2 subgroups: Slow-titration group and Fast-titration group to find out optimum titration of zonisamide. This study will proceed through 25~27 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Epilepsy patients over 15 years old.
  • Occurrence of seizure should be more than one time within recent 3 months and more than two times within recent 6 months.
  • Patients who have not taken antiepileptic drugs (AEDs) in recent 3 months.
  • Female who can be in the month of pregnancy should agree to prevent conception.
  • Patients who agree with Informed Consent Form.

Exclusion criteria

  • Patients who have Myoclonic seizures and/or Absence seizures.
  • Patients who have progressive central nervous system (CNS) disorder.
  • Patients who have serious systemic disorder.
  • Upward of doubled normal serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) level and/or tripled blood urea nitrogen (BUN)/Creatinine levels.
  • Patients who have renal stones.
  • Medical history of medicinal poisoning and/or alcoholism.
  • Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.

Treatment and study plan

zonisamide

Drug

Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.

carbamazepine

Drug

Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.

Primary outcomes

  1. The Percentage of Participants With Seizure Free Rate

    Time frame: 24 weeks

    The percentage of participants who had no seizure during the trial.

Secondary outcomes

  1. The Percentage of Participants With Retention Rate

    Time frame: 24 weeks

    The percentage of participants who completed the trial.

  2. Quality of Life in Epilepsy (QoL-QOLIE31)

    Time frame: 24 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.

Sponsors and collaborators

Lead sponsor

Eisai Korea Inc.

Industry

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
May 20, 2010
Registry last updated
Jan 4, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.