drugset / Trial / NCT06534502

Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures

NCT06534502

Phase 4 Not yet recruiting 40 enrolled Azurity Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this research is to determine the optimal dose, safety and tolerability of zonisamide oral suspension in children ages 1 month to 17 years of age who have partial-onset (focal) seizures. The study consists of four periods: a Screening Period (about 14 days), a Titration Period (8 weeks), a Maintenance Period (4 weeks), and a Follow-Up Period (1 week).

Timeline

Start
2026-09
Primary completion
2027-09
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Zonisamide Other / unclassified 8 mg/kg Oral

Indications