A Study With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Perampanel (E2007) Administered as an Adjunctive Therapy in Subjects With Refractory Partial-onset Seizures

Phase 3

Completed

• Conditions: Partial-onset Seizures
• Interventions: Drug: Placebo; Drug: Perampanel

• Registration Number: NCT01618695
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to confirm the efficacy and safety of perampanel compared to placebo in patients with refractory partial-onset seizures

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-15
• Study First Submitted: 2012-06-11
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-13
• Primary Completion: 2014-09-15
• Results First Submitted: 2020-05-20
• Results First Submitted QC: 2020-05-20
• Study Completion: 2020-05-28
• Results First Posted: 2020-06-05
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 940

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Perampanel	Perampanel	-

Primary Outcome Measures

Name	Time	Method
Core Phase: Percent Change in Seizure Frequency (For All Partial Seizures) Per 28 Days in the Randomization Phase Relative to Pre-randomization Phase (Baseline)	Baseline, Week 19	Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. All partial seizure included simple partial seizures without motor signs, simple partial with motor signs, complex partial, and complex partial with secondary generalized seizures. A simple partial seizure takes place on one side of the brain. Usually, people experiencing a simple partial seizure do not lose consciousness or awareness. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain. The seizure affects people's awareness and may cause them to lose consciousness.

Secondary Outcome Measures

Name	Time	Method
Core Phase: Responder Rate During the Maintenance Period of the Randomization Phase Relative to the Prerandomization Phase (Baseline)- Last Observation Carried Forward (LOCF)	Baseline, Week 19	Responder rate was percentage of participants with greater than or equal to (\>=) 50% reduction in seizure frequency during maintenance period of the randomization phase relative to prerandomization phase (baseline). If the reduction in seizure frequency is less than (\<) 50%, then the participants are considered as non-responders.
Core Phase: Percent Change in Seizure Frequency Per 28 Days For Complex Partial Seizures Plus Secondary Generalized Seizures in the Randomization Phase Relative to the Prerandomization Phase (Baseline)	Baseline, Week 19	Seizure frequency was based on number of seizures per 28 days, calculated as the number of seizures over the entire time interval divided by the number of days in the interval and multiplied by 28. A complex partial seizure is a type of seizure that arises in one lobe of the brain, rather than the whole brain and it affects awareness and may cause in loss of consciousness. Secondary generalized seizures begin in one part of the brain, but then spread to both sides of the brain.
Core Phase: Number of Participants With Clinical Global Impression of Change (CGIC) Scores	Baseline, Week 19	The investigator evaluated each participant for CGIC questionnaire to assess change in participant's disease clinical status from baseline. Assessment evaluated frequency of seizures, severity of seizures, occurrence of adverse events (AEs), and overall functional status of the participant using the 7-point scale. The evaluation used a 7-point scale with the scores 1: Very much improved, 2: Much improved, 3: Minimally improved, 4: No change, 5: Minimally worse, 6: Much worse, 7: Very much worse. Lower score indicated improvement and higher score indicated worsening.

Trial Locations

Locations (11)

Facility #3; 🇹🇭 Tha Muang, Thailand

Facility #6; 🇰🇷 Seoul, Korea, Republic of

Facility #1; 🇹🇭 Tha Muang, Thailand

Eisai Trial Site #1; 🇯🇵 Yamagata, Japan

Facility #2; 🇹🇭 Tha Muang, Thailand

Facility #4; 🇹🇭 Tha Muang, Thailand

Facility #8; 🇰🇷 Seoul, Korea, Republic of

Facility #7; 🇰🇷 Seoul, Korea, Republic of

Eisai Trial Site #3; 🇯🇵 Nagoya, Aichi, Japan

Facility #5; 🇰🇷 Seoul, Korea, Republic of

Eisai Trial Site #2; 🇯🇵 Shizuoka, Japan