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

Epilepsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736162
• Other study ID #: E2007-G000-504
• Status: Completed
• Phase: N/A
• First received: March 30, 2016
• Last updated: March 7, 2017
• Start date: April 2016
• Est. completion date: July 2016

Study information

• Verified date: March 2017
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: July 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Epilepsy
• Partial-Onset Seizures
• Primary Generalized Tonic-Clonic Seizures
• Seizures

Intervention

Other:
• No treatment (intervention) was administered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention rate	The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy	Month 3
Primary	Retention rate	The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy	Month 6
Primary	Retention rate	The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy	Month 12
Primary	Retention rate	The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy	Month 18
Primary	Retention rate	The percentage of participants remaining on perampanel monotherapy treatment after conversion from perampanel adjunctive therapy	Month 24
Primary	Participants remaining on perampanel monotherapy (after conversion from perampanel as adjunctive therapy)		Up to approximately 34 months
Secondary	Percentage of participants receiving perampanel monotherapy out of the total number of participants prescribed perampanel		Up to approximately 34 months
Secondary	Percentage of participants with greater than or equal to 50% reduction in seizure frequency		Up to approximately 34 months
Secondary	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
Secondary	Percentage of participants with greater than or equal to 75% reduction in seizure frequency		Up to approximately 34 months
Secondary	Percentage of participants with categorized percent reductions in seizure frequency		Up to approximately 34 months
Secondary	Percentage of participants with no change or worsening of seizures		Up to approximately 34 months
Secondary	Median percent change in seizure frequency		Up to approximately 34 months
Secondary	Percentage of participants with treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)		Up to approximately 34 months
Secondary	Mean change in body weight		Up to approximately 34 months
Secondary	Maximum dose of perampanel during adjunctive therapy and monotherapy		Up to approximately 34 months
Secondary	Average dose of perampanel during adjunctive therapy and monotherapy		Up to approximately 34 months