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

Epilepsy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00154076
• Other study ID #: E2090-S082-403
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: September 1, 2009
• Start date: September 2005
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Zonisamide
Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.
• Topiramate
Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu

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	Seizure frequency		2, 4, 8, 12, 16, 20, 24 weeks
Secondary	Cognitive function		0, 24 weeks