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NCT01871233 Clinical Trial

An Extended Access Program for Perampanel

Partial Onset Seizures Clinical Trial

Official title:
An Extended Access Program for Perampanel

Clinical Trial Details — Status: No longer available

Administrative data
NCT number NCT01871233
Other study ID # E2007-G000-401
Secondary ID
Status No longer available
Phase
First received
Last updated

Study information
Verified date March 2020
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Recruitment information / eligibility
Status No longer available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 12 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Perampanel
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.

Locations
Country Name City State
Argentina Hospital General De Agudos José María Ramos Mejia Buenos Aires
Argentina Centro De Estudio Y Tratamiento De La Epilepsia Y Sueno - Cetes S.A. Cordoba
Argentina Fundacion Cerebro Y Mente Mendoza Provincia De Mendoza
Australia St Vincent's Hospital Melbourne Fitzroy
Australia Clinical Trials, Epilepsy Research Centre, Melbourne Brain Centre Heidelberg
Australia Royal Melbourne Hospital Parkville
Belgium Uz Antwerpen Edegem
Belgium Uz Gent Ghent
Canada Foothills Medical Center Calgary Albert
Canada London Health Sciences Center London Ontario
Canada Youthdale Treatment Centers Toronto Ontario
Chile Hospital Dr. Sótero Del Río Santiago
Chile Hospital Base Valdivia Servicio De Neurología Valdivia
Czechia Fakultni Nemocnice U Sv. Anny V Brne Brno
Czechia Fakultni Nemocnice Hradec Kralove Hradec Kralove
Czechia Fakultni Nemocnice V Motole Prague
Estonia Oy Neurodiagnostika Ap Tallinn
Estonia Tallinn Children's Hospital Tallinn
Estonia West Tallinn Central Hospital Tallinn
Estonia Tartu University Hospital Tartu
Israel Barzilai Medical Center Ashkelon
Israel Rambam Medical Center Haifa
Israel Edith Wolfson Medical Center Holon
Italy Azienda Ospedaliera Universitaria Federico Ii Napoli
Latvia Childrens Clinical University Hospital Riga
Latvia Outpatient Clinic 'Valmieras Veselibas Centrs' Valmiera
Lithuania Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics Kaunas
Lithuania Klaipeda University Hospital Klaipeda
Lithuania Vilnius University Hospital Santariskes Clinics Vilnius
Malaysia University Malaya Medical Centre Kuala Lumpur
Netherlands Kempenhaeghe Heeze
Netherlands Stichting Epilepsie Instellingen Nederland Hoofddorp
Poland Akademickie Centrum Kliniczne - Szpital Akademii Medycznej W Gdansku Gdansk
Spain Hospital Universitario San Cecilio Granada
Spain Fundacion Jimenez Diaz Madrid
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Universitari I Politècnis La Fe Bulevar Sur Valencia
Thailand King Chulalongkorn Memorial Hospital, Chulalongkorn University Bangkok
Thailand Phramongkutklao Hospital Bangkok
Thailand Maharaj Nakorn Chiang Mai, Chiang Mai University Chiang Mai
Thailand Srinagarind Hospital Khonkaen

Sponsors (1)
Lead Sponsor Collaborator
Eisai Inc.

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Canada,  Chile,  Czechia,  Estonia,  Finland,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Latvia,  Lithuania,  Malaysia,  Netherlands,  Poland,  Spain,  Taiwan,  Thailand, 

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