JPRN-jRCT2080221861CompletedPhase 3
A phase 3 multinational study of E2007 in subjects with refractory partial-onset seizure
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 710
Study Overview
Brief Summary
Adjunctive treatment with perampanel doses of 8 and 12 mg/day was effective in improving seizure control in subjects 12 years and older with refractory partial-onset seizures. Perampanel doses of 4, 8, and 12 mg/day were safe and well tolerated. No new safety signals were identified during adjunctive long-term treatment with perampanel relative to the results for the Core Study. Perampanel demonstrates a favorable risk/benefit ratio in adolescent and adult patients with refractory partial-onset seizures.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 12age old to ot applicable (—)
- Sex
- All
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
- •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
Investigators
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