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An Extended Access Program for Perampanel

Primary Purpose

Partial Onset Seizures

Status
No longer available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Perampanel
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Partial Onset Seizures focused on measuring anti-epileptic drug, Extended Access Program, partial onset seizures, Perampanel

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

  • Fundacion Cerebro Y Mente
  • Hospital General De Agudos José María Ramos Mejia
  • Centro De Estudio Y Tratamiento De La Epilepsia Y Sueno - Cetes S.A.
  • St Vincent's Hospital Melbourne
  • Clinical Trials, Epilepsy Research Centre, Melbourne Brain Centre
  • Royal Melbourne Hospital
  • Uz Antwerpen
  • Uz Gent
  • Foothills Medical Center
  • London Health Sciences Center
  • Youthdale Treatment Centers
  • Hospital Dr. Sótero Del Río
  • Hospital Base Valdivia Servicio De Neurología
  • Fakultni Nemocnice U Sv. Anny V Brne
  • Fakultni Nemocnice Hradec Kralove
  • Fakultni Nemocnice V Motole
  • West Tallinn Central Hospital
  • Oy Neurodiagnostika Ap
  • Tallinn Children's Hospital
  • Tartu University Hospital
  • Barzilai Medical Center
  • Rambam Medical Center
  • Edith Wolfson Medical Center
  • Azienda Ospedaliera Universitaria Federico Ii
  • Childrens Clinical University Hospital
  • Outpatient Clinic 'Valmieras Veselibas Centrs'
  • Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics
  • Klaipeda University Hospital
  • Vilnius University Hospital Santariskes Clinics
  • University Malaya Medical Centre
  • Kempenhaeghe
  • Stichting Epilepsie Instellingen Nederland
  • Akademickie Centrum Kliniczne - Szpital Akademii Medycznej W Gdansku
  • Hospital Universitario San Cecilio
  • Fundacion Jimenez Diaz
  • Hospital Clinico San Carlos
  • Hospital Universitari I Politècnis La Fe Bulevar Sur
  • King Chulalongkorn Memorial Hospital, Chulalongkorn University
  • Phramongkutklao Hospital
  • Maharaj Nakorn Chiang Mai, Chiang Mai University
  • Srinagarind Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 4, 2013
Last Updated
April 15, 2020
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01871233
Brief Title
An Extended Access Program for Perampanel
Official Title
An Extended Access Program for Perampanel
Study Type
Expanded Access

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Onset Seizures
Keywords
anti-epileptic drug, Extended Access Program, partial onset seizures, Perampanel

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Perampanel
Other Intervention Name(s)
E2007
Intervention Description
Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in Studies 207, 307, or 235. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted based on clinical judgment. A minimum daily dose permitted will be 12 mg per day. Treatment will be prescribed as long as clinically appropriate according to the judgment of the treating physician and the approved summary of Product Characteristics (SmPC). Tablets will be available in strengths of 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. Patients will be instructed to take their perampanel tablets once daily, by mouth, before bedtime, and with food.

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

An Extended Access Program for Perampanel

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