Status:
COMPLETED
A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
Lead Sponsor:
Eisai Korea Inc.
Conditions:
Epilepsy
Eligibility:
All Genders
13+ years
Phase:
PHASE4
Brief Summary
To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients over 13 years old (complete the elementary school course).
- Patients had at least two seizures in the past and at least one seizure for the last 3 months before screening.
- Patients had no antiepileptic drugs for the last 4 months.
- Women of childbearing age who agree to contraception during participating this clinical trial.
- Exclusion criteria:
- Pregnancy
- Patients who have progressive neurologic disease
- Allergy to sulfonamides
- Use of acetazolamide within a year
- Hemolytic anemia
- Patients who have abnormal liver function (GOT or GPT) values more than twice the normal values.
- Patients who have abnormal renal function (BUN or Creatinine) values more than three times the normal values.
- Patients who have history of drug or alcohol abuse.
- Glucose-6-phosphate dehydrogenase deficiency.
- Patients who were detected with renal stones on KUB (Kidney-Ureter-Bladder) test.
- Patients who have progressive internal or surgical disease.
- Patients who have progressive psychiatric disease.
- Patients who have mental retardation (IQ 70 and less).
- Patients taking Vit C.
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00154076
Start Date
September 1 2005
End Date
December 1 2008
Last Update
September 2 2009
Active Locations (1)
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1
Daegu Catholic University Medical Center
Daegu, South Korea