Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Patients With Epilepsy

Completed

• Conditions: Epilepsy; Partial-Onset Seizures; Primary Generalized Tonic-Clonic Seizures
• Interventions: Other: No treatment (intervention) was administered

• Registration Number: NCT02736162
• Lead Sponsor: Eisai Inc.

Brief Summary

The primary objective of this study is to assess the retention rate of perampanel when given as secondary monotherapy in routine clinical care.

Detailed Description

This study is a retrospective study of participants who received perampanel as primary or secondary monotherapy at approximately 40 centers in Europe, Asia, and Australia. Primary monotherapy is defined as the administration of perampanel in the absence of any concomitant antiepileptic drugs (AEDs). Secondary (conversion) monotherapy is defined as the conversion of perampanel from adjunctive therapy to monotherapy by withdrawing concomitant AEDs.

Study Timeline

• Study First Submitted: 2016-03-30
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-07
• Study First Posted: 2016-04-13
• Primary Completion: 2016-06
• Study Completion: 2016-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Diagnosis of epilepsy
• Received perampanel as primary or secondary monotherapy at any time between 1 Jan 2013 and 15 Oct 2015
• Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records per local requirements

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Perampanel	No treatment (intervention) was administered	Participants with a diagnosis of epilepsy who received perampanel as primary or secondary (conversion) monotherapy at any time between 1 Jan 2013 and 15 Oct 2015.

Primary Outcome Measures

Name	Time	Method
Participants remaining on perampanel monotherapy (after conversion from perampanel as adjunctive therapy)	Up to approximately 34 months
Retention rate	Month 24	The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy

Secondary Outcome Measures

Name	Time	Method
Percentage of participants with greater than or equal to 75% reduction in seizure frequency	Up to approximately 34 months
Mean change in body weight	Up to approximately 34 months
Percentage of participants receiving perampanel monotherapy out of the total number of participants prescribed perampanel	Up to approximately 34 months
Percentage of participants who were seizure-free for at least 3 months	Up to approximately 34 months	Seizure-free is defined as a terminal remission of seizures
Percentage of participants with no change or worsening of seizures	Up to approximately 34 months
Median percent change in seizure frequency	Up to approximately 34 months
Average dose of perampanel during adjunctive therapy and monotherapy	Up to approximately 34 months
Percentage of participants with categorized percent reductions in seizure frequency	Up to approximately 34 months
Percentage of participants with greater than or equal to 50% reduction in seizure frequency	Up to approximately 34 months
Percentage of participants with treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)	Up to approximately 34 months
Maximum dose of perampanel during adjunctive therapy and monotherapy	Up to approximately 34 months