Low and High Dose Zonisamide in Children as Monotherapy

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Eisai

Status and phase

Completed
Phase 4

Conditions

Epilepsy

Treatments

Drug: zonisamide low dose group
Drug: zonisamide high dose group

Study type

Interventional

Funder types

Industry

Identifiers

NCT01127165
E2090-S082-404

Details and patient eligibility

About

The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.

Enrollment

125 patients

Sex

All

Ages

2 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pediatric patients with epilepsy whose age is 2~15 years old.
  • Patients had at least two seizures for the last 6 months before entry.
  • Patients who had never taken antiepileptic drugs.
  • Patients with no chance of progressive disease based on the result of magnetic resonance imaging (MRI) or electroencephalogram (EEG).
  • Agreement of the guardian is needed.

Exclusion criteria

  • Patients who have progressive central nervous system (CNS) disease.
  • Patients with serious disorder.
  • Patients who have abnormal liver function (serum glutamic oxaloacetic transaminase [SGOT]) or (serum glutamic pyruvic transaminase [SGPT]) values more than twice the normal values.
  • Patients who have abnormal renal function (blood urea nitrogen (BUN) or Creatinine) values more than three times the normal values.
  • Hemolytic anemia.

Trial design

125 participants in 2 patient groups

Zonisamide Low Dose Group
Experimental group
Treatment:
Drug: zonisamide low dose group
Zonisamide High Dose group
Experimental group
Treatment:
Drug: zonisamide high dose group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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