Trials / Not Yet Recruiting
Not Yet RecruitingNCT06534502
Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Zonisamide Oral Suspension (100 mg/5 ml) to Determine a Dosing Regimen in Children 1 Month to 17 Years of Age With Partial-onset Seizures
- Status
- Not Yet Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Azurity Pharmaceuticals · Industry
- Sex
- All
- Age
- 1 Month – 17 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Seizures
- Seizures, Focal
- Seizure, Partial Onset
- Seizure Disorder, Partial
- Seizure, Partial
- Epilepsies, Partial
- Epilepsy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zonisamide Oral Product | Zonisamide oral suspension |
Timeline
- Start date
- 2026-07-01
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
- First posted
- 2024-08-02
- Last updated
- 2026-03-27
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06534502. Inclusion in this directory is not an endorsement.