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.

Study Overview

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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bundang, Korea, Republic of
    • Seoul National Univ. Bundang Hosp.
  • Chungnam, Korea, Republic of
    • Chungnam National Univ. Hosp.
  • Ilsan, Korea, Republic of
    • Dongguk Univ. Ilsan Hosp.
  • Incheon, Korea, Republic of
    • Inha Univ. Hosp.
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Boramae Medical Center
  • Seoul, Korea, Republic of
    • Hallym Univ. Medical Center
  • Seoul, Korea, Republic of
    • Eulji General Hosp.
  • Seoul, Korea, Republic of
    • Ewha Womans Univ. Mokdong Hospital
  • Seoul, Korea, Republic of
    • Hanyang Univ. Medical Center
  • Seoul, Korea, Republic of
    • Konkuk Univ. Medical Center
  • Seoul, Korea, Republic of
    • Seoul National Univ. Hosp.

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

Exclusion criteria:

1. Patients who have Myoclonic seizures and/or Absence seizures.
2. Patients who have progressive central nervous system (CNS) disorder.
3. Patients who have serious systemic disorder.
4. 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.
5. Patients who have renal stones.
6. Medical history of medicinal poisoning and/or alcoholism.
7. Patients who have long-term medication history (more than 6 months) of zonisamide and/or carbamazepine.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: zonisamide; Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.
Active Comparator: 2	Drug: carbamazepine; Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Participants With Seizure Free Rate	The percentage of participants who had no seizure during the trial.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Percentage of Participants With Retention Rate	The percentage of participants who completed the trial.	24 weeks
Quality of Life in Epilepsy (QoL-QOLIE31)	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.	24 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): May 31, 2006
• Primary Completion (Actual): May 31, 2009
• Study Completion (Actual): July 31, 2009

Study Registration Dates

• First Submitted: May 19, 2010
• First Submitted That Met QC Criteria: May 19, 2010
• First Posted (Estimate): May 20, 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, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Anticonvulsants; Sodium Channel Blockers; Antimanic Agents; Cytochrome P-450 Enzyme Inducers; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Cytochrome P-450 CYP3A Inducers; Zonisamide; Carbamazepine
• Other Study ID Numbers: E2090-S082-405