Clinical trial NCT02736162: Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Patients With Epilepsy
Official title: A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Perampanel Given as Monotherapy in Routine Clinical Care in Patients With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Partial-Onset Seizures
Primary Generalized Tonic-Clonic Seizures
Keywords: Perampanel
E2007
Phase 4
Fycompa
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-13
Enrollment: 61
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who received perampanel as primary or secondary monotherapy.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention rate
timeFrame: Month 3
measure: Retention rate
timeFrame: Month 6
measure: Retention rate
timeFrame: Month 12
measure: Retention rate
timeFrame: Month 18
measure: Retention rate
timeFrame: Month 24
measure: Participants remaining on perampanel monotherapy (after conversion from perampanel as adjunctive therapy)
timeFrame: Up to approximately 34 months
Secondary outcomes:
measure: Percentage of participants receiving perampanel monotherapy out of the total number of participants prescribed perampanel
timeFrame: Up to approximately 34 months
measure: Percentage of participants with greater than or equal to 50% reduction in seizure frequency
timeFrame: Up to approximately 34 months
measure: Percentage of participants who were seizure-free for at least 3 months
timeFrame: Up to approximately 34 months
measure: Percentage of participants with greater than or equal to 75% reduction in seizure frequency
timeFrame: Up to approximately 34 months
measure: Percentage of participants with categorized percent reductions in seizure frequency
timeFrame: Up to approximately 34 months
measure: Percentage of participants with no change or worsening of seizures
timeFrame: Up to approximately 34 months
measure: Median percent change in seizure frequency
timeFrame: Up to approximately 34 months
measure: Percentage of participants with treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
timeFrame: Up to approximately 34 months
measure: Mean change in body weight
timeFrame: Up to approximately 34 months
measure: Maximum dose of perampanel during adjunctive therapy and monotherapy
timeFrame: Up to approximately 34 months
measure: Average dose of perampanel during adjunctive therapy and monotherapy
timeFrame: Up to approximately 34 months
Other outcomes:
Locations:
Study officials:
affiliation: Eisai Limited
name: Karen Cartwright, PhD
role: STUDY_DIRECTOR
References: