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

NCT ID: NCT02736162

Last Updated: 2017-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-07-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Epilepsy Partial-Onset Seizures Primary Generalized Tonic-Clonic Seizures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

No treatment (intervention) was administered

Intervention Type OTHER

Interventions

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No treatment (intervention) was administered

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Cartwright, PhD

Role: STUDY_DIRECTOR

Eisai Limited

Other Identifiers

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E2007-G000-504

Identifier Type: -

Identifier Source: org_study_id

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