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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127256
• Other study ID #: E2090-S082-405
• Status: Completed
• Phase: Phase 4
• Start date: May 31, 2006
• Est. completion date: July 31, 2009

Study information

• Verified date: May 2010
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 31, 2009
• Est. primary completion date: May 31, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Participants With Seizure Free Rate	The percentage of participants who had no seizure during the trial.	24 weeks
Secondary	The Percentage of Participants With Retention Rate	The percentage of participants who completed the trial.	24 weeks
Secondary	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