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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00154076
First received: September 8, 2005
Last updated: September 1, 2009
Last verified: August 2009
History of Changes

September 8, 2005
September 1, 2009
September 2005
August 2008   (final data collection date for primary outcome measure)
Seizure frequency [ Time Frame: 2, 4, 8, 12, 16, 20, 24 weeks ] [ Designated as safety issue: Yes ]
Seizure frequency
Complete list of historical versions of study NCT00154076 on ClinicalTrials.gov Archive Site
Cognitive function [ Time Frame: 0, 24 weeks ] [ Designated as safety issue: No ]
Cognitive function
Not Provided
Not Provided
 
A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
Not Provided

To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
  • Drug: Zonisamide
    Initial dose is 100mg/day, increase after 2 weeks to 200mg/day. The maximum dose is 600mg/day.
    Other Name: Zonegran
  • Drug: Topiramate
    Initial dose is 25mg/day, increase every 1 week to 100mg/day. The maximum dose is 400mg/day.
  • Experimental: 1
    Intervention: Drug: Zonisamide
  • Active Comparator: 2
    Intervention: Drug: Topiramate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2008
August 2008   (final data collection date for primary outcome measure)

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.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00154076
E2090-S082-403
Not Provided
Jihee Mun, Eisai Korea Inc.
Eisai Korea Inc.
Not Provided
Study Director: Jihee Mun Eisai Korea Inc.
Eisai Inc.
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP