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

Detailed criteria

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

Drug
Zonisamide Oral Product
Zonisamide oral suspension

Locations (2)

Wake Forest University School of Medicine
Winston-Salem, North Carolina
Le Bonheur Children's Hospital
Memphis, Tennessee

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

Summary

Eligibility

Interventions

Locations (2)

Compensation

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Details

Conditions