A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years

September 6, 2018 updated by: Eisai Inc.
The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a global, observational, cohort study in patients with epilepsy. Multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Universitätsklinikum Innsbruck
      • Linz, Austria, 4020
        • Kepler Universitätsklinikum
      • Wien, Austria, 1130
        • Krankenhaus Wien-Hietzing
  • Belgium
      • Battice, Belgium
        • Eisai Site# 2405
      • Bruxelles, Belgium, 1070
        • Hôpital Erasme
      • Bruxelles, Belgium
        • Eisai Site# 2404
      • Duffel, Belgium
        • Eisai Site# 2406
      • Leuven, Belgium, 3000
        • UZ Leuven
      • Liège, Belgium
        • Eisai Site# 2409
      • Ottignies, Belgium
        • Eisai Site# 2403
      • Ruddershove, Belgium
        • Eisai Site# 2408
      • Woluwe-Saint-Lambert, Belgium
        • Eisai Site# 2407
      • Yvoir, Belgium
        • Eisai Site# 2402
  • Czechia
      • Beroun, Czechia
        • Eisai Site# 2601
      • Brno, Czechia
        • Eisai Site# 2600
      • Hradec Králové, Czechia
        • Eisai Site# 2606
      • Náchod, Czechia
        • Eisai Site# 2602
      • Ostrava, Czechia, 72200
        • Cerebrovaskularni poradna s.r.o.
      • Praha, Czechia
        • Eisai Site# 2603
  • Israel
      • Be'er Sheva, Israel
        • Eisai Site# 2013
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • H̱olon, Israel, 58100
        • Edith Wolfson Medical Center
      • Jerusalem, Israel
        • Kiryat Hadassah
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center
      • Nahariya, Israel, 22100
        • Western Galilee Hospital
      • Petach Tikva, Israel, 49202
        • Schneider Children's Medical Center of Israel
      • Ramat Gan, Israel
        • The Chaim Sheba Medical Center
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center
      • Tel Aviv-Yafo, Israel
        • Eisai Site# 2003
      • Tel Aviv-Yafo, Israel
        • Eisai Site# 2012
      • Tel-Hashomer, Israel
        • Eisai Site# 2008
  • Sweden
      • Göteborg, Sweden, SE-41345
        • Sahlgrenska Universitetssjukhuset
      • Linköping, Sweden, 58185
        • Universitetssjukhuset i Linköping
  • United Kingdom
      • Bristol, United Kingdom
        • Eisai Site# 1607
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Lincoln, United Kingdom
        • Eisai Site# 1611
      • London, United Kingdom
        • Great Ormond Street Hospital
      • London, United Kingdom
        • Eisai Site# 1604
      • London, United Kingdom
        • Eisai Site# 1608
      • London, United Kingdom
        • Eisai Site# 1609
      • Newcastle, United Kingdom
        • Eisai Site# 1612
      • Truro, United Kingdom
        • Eisai Site# 1606

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 (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Epilepsy patients prescribed adjunctive treatment in countries where perampanel has received marketing approval. Multiple treating physicians will prescribe perampanel to patients, who then will be observed for approximately 52 weeks.

Description

Inclusion Criteria

  1. Male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent
  2. Patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit
  3. Patients who provide informed consent

Exclusion Criteria

  1. Participation in another study involving administration of an investigational drug or device whilst participating in this observational study
  2. Prior participation in a perampanel clinical study
  3. Hypersensitivity to perampanel

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
Perampanel
Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment
Drug: Perampanel
Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Treatment Emergent Adverse Events (TEAEs) of interest
Time Frame: Up to 52 weeks and 2 weeks of follow-up
Assessment of events of dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction.
Up to 52 weeks and 2 weeks of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of unintended pregnancy
Time Frame: Up to 52 weeks
Up to 52 weeks
Incidence of off-label use
Time Frame: Up to 52 weeks
Up to 52 weeks
Summary scores for the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Screening, Week 52
Screening, Week 52
Number of TEAEs in the patient subpopulations of interest
Time Frame: Up to 52 weeks and 2 weeks of follow-up
TEAEs observed in the specified subpopulations of patients could also be made in order to get a better understanding of whether any of these particular potential risk factors (e.g., old age, cardiovascular disease) define groups with greater or lesser risk.
Up to 52 weeks and 2 weeks of follow-up
Clinical Global Impression of Change
Time Frame: Week 52
Assessment of disease severity will utilize the Clinical Global Impression of Change (CGI-C) scale at end of treatment to evaluate change in disease status since initiation of treatment.
Week 52

Collaborators and Investigators

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

Sponsor

Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 6, 2014

Primary Completion (Actual)

January 31, 2018

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

December 17, 2013

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 13, 2014

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 6, 2018

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2007-G000-402

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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