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

A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Routine Clinical Care in Patients With Epilepsy

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

Study Overview

• Status: Completed
• Conditions: Epilepsy; Primary Generalized Tonic-Clonic Seizures; Partial-Onset Seizures
• Intervention / Treatment: Other: No treatment (intervention) was administered

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 Type: Observational
• Enrollment (Actual): 61

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants who received perampanel as primary or secondary monotherapy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Perampanel; 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.	Other: No treatment (intervention) was administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rate	The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy	Month 3
Retention rate	The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy	Month 6
Retention rate	The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy	Month 12
Retention rate	The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy	Month 18
Retention rate	The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy	Month 24
Participants remaining on perampanel monotherapy (after conversion from perampanel as adjunctive therapy)		Up to approximately 34 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants receiving perampanel monotherapy out of the total number of participants prescribed perampanel		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 who were seizure-free for at least 3 months	Seizure-free is defined as a terminal remission of seizures	Up to approximately 34 months
Percentage of participants with greater than or equal to 75% reduction in seizure frequency		Up to approximately 34 months
Percentage of participants with categorized percent reductions in seizure frequency		Up to approximately 34 months
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
Percentage of participants with treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)		Up to approximately 34 months
Mean change in body weight		Up to approximately 34 months
Maximum dose of perampanel during adjunctive therapy and monotherapy		Up to approximately 34 months
Average dose of perampanel during adjunctive therapy and monotherapy		Up to approximately 34 months

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Investigators: Study Director: Karen Cartwright, PhD, Eisai Limited

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimate): April 13, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2017
• Last Update Submitted That Met QC Criteria: March 7, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Perampanel; Phase 4; Fycompa; E2007
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: E2007-G000-504