Clinical trial NCT01127256: Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Official title: Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epilepsy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-20
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Percentage of Participants With Seizure Free Rate
timeFrame: 24 weeks
Secondary outcomes:
measure: The Percentage of Participants With Retention Rate
timeFrame: 24 weeks
measure: Quality of Life in Epilepsy (QoL-QOLIE31)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: Seoul National Univ. Bundang Hosp.
city: Chungnam
country: Korea, Republic of
facility: Chungnam National Univ. Hosp.
city: Ilsan
country: Korea, Republic of
facility: Dongguk Univ. Ilsan Hosp.
city: Incheon
country: Korea, Republic of
facility: Inha Univ. Hosp.
city: Seoul
country: Korea, Republic of
facility: Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Eulji General Hosp.
city: Seoul
country: Korea, Republic of
facility: Ewha Womans Univ. Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym Univ. Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang Univ. Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk Univ. Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National Univ. Hosp.
Study officials:
affiliation: Medical Department, Eisai Korea Inc.
name: Jihee Mun
role: STUDY_DIRECTOR
References: