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

NCT06534502 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: AZ04.001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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 Disorder, Partial; Seizure, Partial Onset; Seizure, Partial; Epilepsies, Partial; Epilepsy

Keywords

Partial-onset (focal) seizures; Pediatrics; ZONISADE; Zonisamide

Outcome Measures

Primary Outcomes (1)

• Concentration of serum zonisamide

  The concentration in serum of zonisamide following administration of zonisamide oral suspension, 100 mg/5 ml

  Up to 15 weeks

Secondary Outcomes (3)

• Incidence of treatment-emergent adverse events (TEAEs)

  Up to 15 weeks

• Number and/or percentage of participants who discontinued the study because of adverse events

  Up to 15 weeks

• Number and/or percentage of participants who required zonisamide dose reduction because of TEAEs.

  Up to 15 weeks

Other Outcomes (1)

• Change from baseline in seizure frequency

  Up to 15 weeks

Study Arms (1)

Zonisamide Oral Suspension

EXPERIMENTAL

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).

Drug: Zonisamide Oral Product

Interventions

Zonisamide Oral Product DRUG

Zonisamide oral suspension

Also known as: ZONISADE, Zonisamide oral suspension

Zonisamide Oral Suspension

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric participants (ages 1 month to 17 years of age, inclusive) will be considered eligible for the study based on the following criteria:
• Voluntarily obtained informed consent from parent/legal guardian of the participant and assent from the participant, when appropriate.
• Willing and able to follow protocol specific requirements.
• Participant of 1 month to 17 years of age, inclusive (at time of consent).
• Participant diagnosed with partial-onset (focal) seizures, with or without secondary generalization as per current International League Against Epilepsy (ILAE) classification of seizures. Participants with both focal-onset and generalized-onset seizures are eligible, but only focal-onset seizures count toward baseline seizure enrollment criteria. Tonic-clonic and tonic seizures with unknown onset are presumed to be focal-onset unless there are clear clinical and EEG data suggesting generalized-onset.
• Participant with seizure occurrence more than once in the past three (3) months and more than two (2) times in the past six (6) months.
• Participant on a stable regimen of anti-epilepsy drugs (AEDs) for at least 30 days before screening
• Participant with acceptable laboratory investigations:
• Hemoglobin within normal range
• Alanine aminotransferase (ALT) within normal range
• Aspartate aminotransferase (AST) up to 1.5 x upper limit of normal (ULN)
• Bilirubin within normal range
• Creatinine clearance within normal range
• If male participant is able to father children must be willing to use a highly effective method of contraception for at least one month after the last dose of investigational product if at risk of pregnancy with her/his partner. If female participant has reached menarche, the participant is authorized to participate in this clinical study if additional criteria are met.
• At screening:

You may not qualify if:

• Pediatric participant will be excluded from the study based on the following criteria:
• Known hypersensitivity to zonisamide or to any component of the investigational product or to sulfonamides.
• Participant who is pregnant or nursing.
• Participant with exclusively generalized-onset seizures.
• Participant with predisposition to nephrolithiasis or prior history of kidney stone(s).
• Participant who is underweight (weight-for-age \<2 standard deviation (SD) from the median of the World Health Organization (WHO) Child Growth Standards) or have a decreased appetite.
• Participant currently on or scheduled to receive carbonic anhydrase inhibitors such as topiramate or acetazolamide.
• Participant currently on or are scheduled to receive drugs known to have pharmacokinetic (PK) interaction.
• Participant who has previously received zonisamide.
• Participant with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
• Participant who has degenerative or metabolic disease of the brain.
• Participant with history of psychiatric disorder (excluding stable attention deficit hyperactivity disorder (ADHD), mood disorder on adequate treatment).
• Participant has any condition which, in the Investigator's opinion, would make it unsafe for the participant to participate in this study.
• Participant who has participated in other clinical study 30 days prior to enrollment in this study or 4-5 half lives of investigational drug, whichever is longer.
• Participant who uses alcohol or is currently on or scheduled to receive other central nervous system (CNS) depressants.

Sponsors & Collaborators

• Azurity Pharmaceuticals: lead

Study Sites (2)

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27101, United States

Location

Le Bonheur Children's Hospital

Memphis, Tennessee, 38103, United States

Location

MeSH Terms

Conditions

Seizures; Epilepsies, Partial; Epilepsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

David Sequeira, PhD

CONTACT

1-800-461-7449; david.sequeira@azurity.com

Meredith Knaak

CONTACT

meredith.knaak@azurity.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)