A phase 3 multinational study of E2007 in subjects with refractory partial-onset seizure

Phase 3

Completed

• Conditions: Refractory partial-onset seizure

• Registration Number: JPRN-jRCT2080221861
• Lead Sponsor: Eisai Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-23
• Results First Posted: 2017-12-17
• Study Completion: 2020-05-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 710

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Percent change in seizure frequency per 28 days during the Randomization Phase relative to baseline

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>Efficacy:<br>Proportion of subjects who had at least a 50% reduction in seizure frequency per 28 days relative to the Prerandomization Phase