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
Azurity Pharmaceuticals
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).
Eligibility
- Age range
- 0–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Pediatric participants (ages 1 month to 17 years of age, inclusive) will be considered eligible for the study based on the following criteria: 1. Voluntarily obtained informed consent from parent/legal guardian of the participant and assent from the participant, when appropriate. 2. Willing and able to follow protocol specific requirements. 3. Participant of 1 month to 17 years of age, inclusive (at time of consent). 4. Participant diagnosed with partial-onset (focal) seizures, with or without secondary generalization as per current International League Against…
Interventions
- DrugZonisamide Oral Product
Zonisamide oral suspension
Locations (2)
- Wake Forest University School of MedicineWinston-Salem, North Carolina
- Le Bonheur Children's HospitalMemphis, Tennessee