Low and High Dose Zonisamide in Children as Monotherapy

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Korea Inc.
• Treatments: Zonisamide

Criteria

Inclusion criteria:

1. Pediatric patients with epilepsy whose age is 2~15 years old.

2. Patients had at least two seizures for the last 6 months before entry.

3. Patients who had never taken antiepileptic drugs.

4. Patients with no chance of progressive disease based on the result of magnetic resonance imaging (MRI) or electroencephalogram (EEG).

5. Agreement of the guardian is needed.

Exclusion criteria:

1. Patients who have progressive central nervous system (CNS) disease.

2. Patients with serious disorder.

3. Patients who have abnormal liver function (serum glutamic oxaloacetic transaminase [SGOT]) or (serum glutamic pyruvic transaminase [SGPT]) values more than twice the normal values.

4. Patients who have abnormal renal function (blood urea nitrogen (BUN) or Creatinine) values more than three times the normal values.

5. Hemolytic anemia.