Low and High Dose Zonisamide in Children as Monotherapy

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

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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