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

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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)

140 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: Zonisamide
2
Active Comparator group
Treatment:
Drug: Topiramate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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