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: Zonisamide
Drug: Topiramate

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

  • 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.

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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