An Extended Access Program for Perampanel

April 15, 2020 updated by: Eisai Inc.

The Extended Access Program (EAP) is a managed access programme for Perampanel. The main objective of this EAP is to ensure that patients participating in studies E2007-A001-207, E2007-G000-307, or E2007-G000-235 continue to have access to perampanel until such time perampanel tablets become commercially available for the treatment of Partial Onset Seizures (POS) in the country in which they reside. This EAP will consist of 2 phases:

  • Screening: The patient will start the program once the Screening assessments are completed and the patient is qualified for participation.
  • Treatment: Additional assessments, physical examinations, and dosage changes will be clinically determined by the treating physician.

Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in previous study. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted (i.e., added,removed, or changed in dose) based on clinical judgment.

Treatment will be prescribed as long as clinically appropriate according to the judgement of the treating physician and the approved Summary of Product Characteristics (SmPC).

The program will complete in a staggered fashion, country by country, as and when perampanel becomes commercially available for the treatment of POS in each country.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

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

  • Argentina
      • Buenos Aires, Argentina
      • Buenos Aires, Argentina, C1221ADC
        • Hospital General de Agudos Jose Maria Ramos Mejía
      • Cordoba, Argentina
        • Centro De Estudio Y Tratamiento De La Epilepsia Y Sueno - Cetes S.A.
      • Rosario, Argentina
      • San José Guaymallén, Argentina
      • San Miguel de Tucumán, Argentina
    • Provincia De Mendoza
      • Mendoza, Provincia De Mendoza, Argentina, M5519FNF
        • Fundacion Cerebro Y Mente
  • Australia
      • Fitzroy, Australia
      • Fitzroy, Australia, VIC 3065
        • St Vincent's Hospital Melbourne
      • Heidelberg, Australia, VIC 3081
        • Clinical Trials, Epilepsy Research Centre, Melbourne Brain Centre
      • Parkville, Australia, VIC 3050
        • Royal Melbourne Hospital
      • Victoria, Australia
  • Belgium
      • Edegem, Belgium
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Gent, Belgium
      • Ghent, Belgium, 9000
        • UZ Gent
      • Ottignies, Belgium
  • Canada
      • Calgary, Canada
      • London, Ontario, Canada
    • Albert
      • Calgary, Albert, Canada, T2N 2T9
        • Foothills Medical Center
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Center
      • Toronto, Ontario, Canada, M5B 1T9
        • Youthdale Treatment Centers
  • Chile
      • Puente Alto, Chile
      • Santiago, Chile
      • Santiago, Chile
        • Hospital Dr. Sótero del Río
      • Valdivia, Chile
      • Valdivia, Chile
        • Hospital Base Valdivia Servicio de Neurología
  • Czechia
      • Brno, Czechia, 656 91
        • Fakultni Nemocnice u sv. Anny v Brne
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Ostrava, Czechia
      • Prague, Czechia, 150 06
        • Fakultni Nemocnice V Motole
  • Estonia
      • Laagri, Estonia
      • Tallinn, Estonia, 10617
        • West Tallinn Central Hospital
      • Tallinn, Estonia, 13419
        • Tallinn Children's Hospital
      • Tallinn, Estonia, 13419
        • Oy Neurodiagnostika Ap
      • Tartu, Estonia, 51014
        • Tartu University Hospital
  • Finland
      • Vantaa, Finland
  • Greece
      • Greece, Greece
  • Hong Kong
      • Kwai Chung, Hong Kong
  • Hungary
      • Budapest, Hungary
  • Israel
      • Ashkelon, Israel, 78278
        • Barzilai Medical Center
      • Haifa, Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
      • Holon, Israel, 58100
        • Edith Wolfson Medical Center
      • Netanya, Israel
  • Italy
      • Napoli, Italy
      • Napoli, Italy, 80131
        • Azienda Ospedaliera Universitaria Federico II
  • Latvia
      • Prague, Latvia
      • Riga, Latvia
      • Riga, Latvia, Lv-1004
        • Childrens Clinical University Hospital
      • Valmiera, Latvia, Lv 4201
        • Outpatient Clinic 'Valmieras Veselibas Centrs'
  • Lithuania
      • Kaunas, Lithuania
      • Kaunas, Lithuania, LT-50009
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics
      • Klaipeda, Lithuania, LT-92288
        • Klaipeda University Hospital
      • Vilnius, Lithuania, Lt-08661
        • Vilnius University Hospital Santariskes Clinics
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Petaling Jaya, Malaysia
  • Netherlands
      • Haarlem, Netherlands
      • Heeze, Netherlands, 5591
        • Kempenhaeghe
      • Hoofddorp, Netherlands, 2130
        • Stichting Epilepsie Instellingen Nederland
  • Poland
      • Gdansk, Poland
      • Gdansk, Poland, 80-952
        • Akademickie Centrum Kliniczne - Szpital Akademii Medycznej W Gdansku
  • Spain
      • Albacete, Spain
      • Granada, Spain
      • Granada, Spain, 18012
        • Hospital Universitario San Cecilio
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain
      • Valencia, Spain
      • Valencia, Spain, 46026
        • Hospital Universitari I Politècnis La Fe Bulevar Sur
  • Taiwan
      • Tainan, Taiwan
      • Taiwan, Taiwan
      • Taoyuan, Taiwan
  • Thailand
      • Bangkok, Thailand, 10400
        • Phramongkutklao Hospital
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital, Chulalongkorn University
      • Bangplee, Thailand
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai, Chiang Mai University
      • Khonkaen, Thailand, 40002
        • Srinagarind Hospital

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 to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are participating in either Study 207, Study 307, or Study 235 and who in the opinion of the treating physician, continue to benefit from treatment with perampanel (revised per Amendment 01)
  • Patients who provide informed consent where applicable per local requirements.
  • Female patients of childbearing potential must agree for the duration of the program and for a period of at least 1 month following last dose of perampanel to be abstinent or to commit to the consistent and correct use of a medically acceptable method of birth control (e.g., a double-barrier method [condom plus spermicide, condom plus diaphragm with spermicide])

Exclusion Criteria:

  • Patients residing in countries where perampanel is commercially available for the treatment of POS
  • Female patients who are lactating, pregnant, or planning to become pregnant

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?

Collaborators and Investigators

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

Sponsor

Eisai Inc.

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 Registration Dates

First Submitted

June 4, 2013

First Submitted That Met QC Criteria

June 4, 2013

First Posted (ESTIMATE)

June 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2007-G000-401

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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