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

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Azurity Pharmaceuticals
Study ID
NCT06534502
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Epilepsies, Partial
  • Epilepsy
  • Seizure Disorder, Partial
  • Seizure, Partial
  • Seizure, Partial Onset
  • Seizures
  • Seizures, Focal

Eligibility Criteria

Sex
ALL
Age
1 Month - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Zonisamide Oral Product — DRUG
    Zonisamide oral suspension

Study Details

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).

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zonisamide Oral Suspension
    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).

Primary Outcome Measure

Concentration of serum zonisamide [ Time Frame: Up to 15 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Wake Forest University School of MedicineWinston-SalemNorth Carolina27101
Gautam Popli, MBBS (PRINCIPAL_INVESTIGATOR)
Le Bonheur Children's HospitalMemphisTennessee38103
James Wheless, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Winston-Salem, NC

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
Wake Forest University School of Medicine· Winston-Salem, NCLe Bonheur Children's Hospital· Memphis, TN

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