Epilepsy
Conditions
Brief summary
To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
Interventions
DRUGZonisamide
Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.
DRUGTopiramate
Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.
Sponsors
Eisai Korea Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients over 13 years old (complete the elementary school course). 2. Patients had at least two seizures in the past and at least one seizure for the last 3 months before screening. 3. Patients had no antiepileptic drugs for the last 4 months. 4. Women of childbearing age who agree to contraception during participating this clinical trial.
Exclusion criteria
1. Pregnancy 2. Patients who have progressive neurologic disease 3. Allergy to sulfonamides 4. Use of acetazolamide within a year 5. Hemolytic anemia 6. Patients who have abnormal liver function (GOT or GPT) values more than twice the normal values. 7. Patients who have abnormal renal function (BUN or Creatinine) values more than three times the normal values. 8. Patients who have history of drug or alcohol abuse. 9. Glucose-6-phosphate dehydrogenase deficiency. 10. Patients who were detected with renal stones on KUB (Kidney-Ureter-Bladder) test. 11. Patients who have progressive internal or surgical disease. 12. Patients who have progressive psychiatric disease. 13. Patients who have mental retardation (IQ 70 and less). 14. Patients taking Vit C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seizure frequency | 2, 4, 8, 12, 16, 20, 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Cognitive function | 0, 24 weeks |
Countries
South Korea
Outcome results
None listed