About this trial
Primary objective: To evaluate the safety and tolerability of cenobamate in Japanese pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Eligibility criteria
Qualifiers
Japanese male or female patients aged 2 to under 18 years at the time of informed consent.
Patients diagnosed with epilepsy as having POS with uncontrolled seizures at least 6 months prior to informed consent, regardless of the presence or absence of secondarily generalized seizures.
Patients who have had POS at least once in 4 weeks before registration. Seizure information can be obtained from the participant's own retrospective patient epilepsy diary, etc.
Participants must have been treated with 1 to 3 ASMs at stable doses for at least 2 months before registration.
Disqualifiers
Patients with a history of status epilepticus requiring hospitalization within 3 months before registration.
Patients with a history of non-epileptic psychogenic seizures.
Patients with simple partial seizures without motor symptoms or idiopathic generalized epilepsy.
Patients diagnosed with Lennox-Gastaut syndrome.
Trial design
Treatments tested in this trial
- Cenobamate (tablet) for 12 to < 18 year olds
- Cenobamate (syrup) for 2 to < 18 year olds