Clinical Trial

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

Not Yet Recruiting Phase 4
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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).
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2024-07-30; most recent amendment 2026-06-02.
Trial Details
NCT Number NCT06534502
Lead Sponsor Azurity Pharmaceuticals
Conditions Seizures, Seizures, Focal, Seizure, Partial Onset, Seizure Disorder, Partial, Seizure, Partial, Epilepsies, Partial, Epilepsy
Enrollment 40 participants
Start Date 2026-09
Primary Completion 2027-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-04