Refractory partial-onset seizure
Conditions
Sponsors
Eisai Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or femal and greater than or equal to 12 years of age 2. Have a diagnosis of epilepsy with partial seizures with or without secondarily generalized seizures 3. Subjects with computed tomography (CT) or magnetic imaging (MRI) diagnosis 4. Subjects who had been treated for at least 12 weeks but confirmed to be uncontrolled with more than one standard AED for 2 years before enrollment 5. during the 6-week Prerandomization Phase, subjects must have had greater than or equal to 5 partial seizures per 6-week 6. Are on a stable dose and administration of the same concomitant AED(s) for 1 month prior to Visit 1
Exclusion criteria
Exclusion criteria: 1. Presence of nonmotor simple partial seizures only 2. Presence of primary generalized epilepsies or seizures, such as absences and/or myoclonic epilepsies 3. Presence or previous history of Lennox-Gastaut syndrome 4. A history of status epilepticus within 1 year before enrollment in Prerandomization Phase 5. Seizure clusters where individual seizures cannot be counted 6. A history of psychogenic seizures within 5 years before enrollment in Prerandomization Phase
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Efficacy: Proportion of subjects who had at least a 50% reduction in seizure frequency per 28 days relative to the Prerandomization Phase | — |
Primary
| Measure | Time frame |
|---|---|
| efficacy Percent change in seizure frequency per 28 days during the Randomization Phase relative to baseline | — |
Countries
Asia except Japan, Japan, Oceania
Outcome results
None listed