Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Yea… (NCT06534502) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures
United States40 participantsStarted 2026-07
Plain-language 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).
Who can participate
Age range1 Month – 17 Years
SexALL
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Inclusion 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
Exclusion criteria
✕. Known hypersensitivity to zonisamide or to any component of the investigational product or to sulfonamides.
. 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.