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

StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

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  1. Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Site details revised at 1 of 2 sites
  2. Start date: Jul 2026 to Sep 2026v7
  3. Primary and study completion dates: Sep 2026 to Sep 2027
    • Start date: Dec 2025 to Jul 2026
    v6
  4. Start date: Jul 2025 to Dec 2025v5
  5. Start date: Feb 2025 to Jul 2025
    • Study sites: 0 to 2
    • Primary and study completion dates: Mar 2026 to Sep 2026
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study Identification, Study Status, Oversight, Contacts/Locationsv3
  2. Primary and study completion dates: Jun 2025 to Mar 2026
    • Start date: Sep 2024 to Feb 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06534502
Lead Sponsor Azurity Pharmaceuticals
Conditions
(from sponsor)		 Seizures, Seizures, Focal, Seizure, Partial Onset, Seizure Disorder, Partial, Seizure, Partial, Epilepsies, Partial, Epilepsy
Related terms Epilepsies, Partial, Epilepsy, Seizures
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov