Phase 4
N=125
Low and High Dose Zonisamide in Children as Monotherapy
Epilepsy
Bottom Line
View on ClinicalTrials.gov: NCT01127165 ↗Enrolled (actual)
125
Serious AEs
2.4%
Results posted
Jul 2012
Primary outcome: Primary: Percentage of Participants Who Were Assessed As Seizure Free — 63.1; 57.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- zonisamide low dose group (Drug); zonisamide high dose group (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Eisai Korea Inc.
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Were Assessed As Seizure Free |
63.1; 57.6 | — |
| SECONDARY Change in Cognitive Assessment Korean-Wechsler Intelligence Scale for Children (K-WISC-Ⅲ) |
-1.3913; 0.1071 | — |
| SECONDARY Change in Behavior Assessment Korea-Child Behavior Checklist (K-CBCL) |
-5.259; -1.611 | — |
| SECONDARY Change in Korean-Quality of Life Childhood Epilepsy (K-QOLCE) |
4.7931; 1.2286 | — |
Summary
The purpose of this study is to confirm the adjustment dosage of zonisamide as monotherapy in children with epilepsy.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01127165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.