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).