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).
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.
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).
Single group
Zonisamide Oral Product
DrugZonisamide oral suspension
Concentration of serum zonisamide
The concentration in serum of zonisamide following administration of zonisamide oral suspension, 100 mg/5 ml
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events (TEAEs), serious and non-serious, reported throughout the study.
Number and/or percentage of participants who discontinued the study because of adverse events
Number and/or percentage of participants who discontinued the study because of adverse events
Number and/or percentage of participants who required zonisamide dose reduction because of TEAEs.
Number and/or percentage of participants who required zonisamide dose reduction because of TEAEs.
Change from baseline in seizure frequency
Change from baseline in seizure frequency
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