Zonisamide for Partial Seizures

Recruiting at 1 trial location

Overseen By David Sequeira, PhD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Azurity Pharmaceuticals

Must be taking: Anti-epilepsy drugs

Must not be taking: Carbonic anhydrase inhibitors

Disqualifiers: Generalized seizures, Kidney stones, Underweight, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Evan Scullin, MD

Principal Investigator

Azurity Pharmaceuticals, Inc.

Eligibility Criteria

This trial is for children aged 1 month to 17 years with partial-onset seizures. They must be on a stable anti-epilepsy drug regimen for at least 30 days and have had more than one seizure in the past three months. Infants under six months are assessed individually. Participants need normal hemoglobin and liver enzyme levels, consent from guardians, and willingness to follow the study's protocol.

Inclusion Criteria

I am between 1 month and 17 years old.

My hemoglobin levels are within the normal range.

My guardian and I have both agreed to my participation in this study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Titration

Participants receive zonisamide starting at 1 mg/kg/day, increasing weekly over 8 weeks

8 weeks

Maintenance

Participants receive up to 8 mg/kg/day of zonisamide for 4 weeks

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Zonisamide

Trial Overview The study tests Zonisamide oral suspension's optimal dose, safety, and tolerability in young patients with epilepsy. It includes a two-week screening, eight weeks of dosage adjustments (titration), four weeks where the dose remains the same (maintenance), followed by one week of follow-up.

Participant Groups

Group I: Zonisamide Oral Suspension Experimental Treatment 1 Intervention

Zonisamide Oral Suspension, 100 mg/5 ml administered orally twice daily * Titration Period: 1 mg/kg/day administered as a divided dose of 0.5 mg/kg twice daily for 2 weeks, then increased by 1 mg/kg/day (as divided doses) at weekly intervals in Weeks 3 to 8. * Maintenance Period: Up to 8 mg/kg/day given as a divided dose twice a day for 4 weeks (i.e., Weeks 9 to 12).

Who Is Running the Clinical Trial?

Azurity Pharmaceuticals

Lead Sponsor

Trials

3

Recruited

240+