A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Routine Clinical Care in Patients With Epilepsy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 61
- Primary Endpoint
- Participants remaining on perampanel monotherapy (after conversion from perampanel as adjunctive therapy)
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Participants remaining on perampanel monotherapy (after conversion from perampanel as adjunctive therapy)
Time Frame: Up to approximately 34 months
Retention rate
Time Frame: Month 24
The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy
Secondary Outcomes
- 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)
- 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)