A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
NCT ID: NCT00154076
Last Updated: 2009-09-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
140 participants
INTERVENTIONAL
2005-09-30
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Zonisamide
Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.
2
Topiramate
Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
ALL
No
Sponsors
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Eisai Korea Inc.
INDUSTRY
Responsible Party
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Eisai Korea Inc.
Principal Investigators
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Jihee Mun
Role: STUDY_DIRECTOR
Eisai Korea Inc.
Locations
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Daegu Catholic University Medical Center
Daegu, , South Korea
Countries
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Other Identifiers
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E2090-S082-403
Identifier Type: -
Identifier Source: org_study_id