A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With Epilepsy

January 13, 2020 updated by: Eisai Co., Ltd.

A Post Marketing Observational Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Epilepsy Patients

The purpose of the study is to evaluate the safety and efficacy of Fycompa® (perampanel) for the adjunctive treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy aged 12 years and older.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with epilepsy aged 12 years or older.

Description

Inclusion Criteria:

  1. Male and female participants aged 12 years and older
  2. Participants who were diagnosed with partial-onset seizures with or without secondarily generalized seizures.
  3. Participants who were appropriate to receive Fycompa® as an adjunctive treatment participants starting at Visit 0 according to investigator's judgment.
  4. Participants who had provided written informed consent

Exclusion Criteria:

  1. Participants not fit to receive Fycompa® as per the latest prescribing information.
  2. Participants who were participating in a clinical trial, at the time of the study.
  3. Participants who showed evidence of clinically significant disease (cardiac, respiratory, gastrointestinal, renal disease, etc.) that in the opinion of the Investigators could affect the participant's safety or trial conduct.
  4. Participants who according to the Investigators would not be able to comply with study procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fycompa® (perampanel)
Fycompa® (perampanel) (oral tablets) treatment will be initiated at 2 milligram (mg) once daily according to the approved package insert, as an add-on drug in addition to other anti-epileptic drugs (AEDs) as prescribed by physician. The dose will be increased based on clinical response and tolerability (by increments of 2 mg/day to a maintenance dose of 4 to 12 mg/day) and participants will be enrolled and observed prospectively for up to 54 Weeks.
Drug: Perampanel
Perampanel tablets.
Other Names:
  • Fycompa
  • E2007

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)
Time Frame: Up to 54 Weeks
AESI will include medication errors, lack of therapeutic efficacy, overdose, abuse, misuse, occupational exposure, paternal exposure and off label use, pregnancy, and exposure to drug during breast feeding.
Up to 54 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in 28-day Seizure Count at the End of Treatment Period (Week 52)
Time Frame: Baseline, Week 52
Baseline, Week 52
Response Rate
Time Frame: Baseline, Week 12, Week 24 and Week 52
Response rate will be defined as number of participants with response defined as more than or equal to (>=) 50 percent (%) reduction in 28-day seizure frequency from Baseline.
Baseline, Week 12, Week 24 and Week 52
Change From Baseline in Clinical Global Impression of Change (CGIC) Scores
Time Frame: Baseline, Week 12, Week 24 and Week 52
The CGIC is an assessment performed by the clinician, evaluating the change in the participant's symptoms over time. Assessment will be implemented based on frequency of seizure, severity of seizures, adverse events, and overall conditions on a 7-point scale with the scores as 1: very much improved, 2: much improved, 3: minimally improved, 4: no change, 5: minimally worse, 6: much worse, 7: very much worse.
Baseline, Week 12, Week 24 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 11, 2016

Primary Completion (ACTUAL)

July 3, 2017

Study Completion (ACTUAL)

July 3, 2017

Study Registration Dates

First Submitted

January 13, 2020

First Submitted That Met QC Criteria

January 13, 2020

First Posted (ACTUAL)

January 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2007-M065-411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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