A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

Eisai

Status and phase: Completed; Phase 4

Conditions: Epilepsy

Treatments: Drug: Topiramate; Drug: Zonisamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00154076

E2090-S082-403

Details and patient eligibility

About

To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

Enrollment: 140 estimated patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Zonisamide

2

Active Comparator group

Treatment:

Drug: Topiramate