Back to resultsAn Extended Access Program (EAP) for Perampanel
Primary Purpose
Primary Generalized Tonic-Clonic or Partial Onset Seizures, Lennox Gastaut Syndrome
Status
Available
Phase
Locations
International
Study Type
Expanded Access
Intervention
Perampanel
Sponsored by
About this trial
This is an expanded access trial for Primary Generalized Tonic-Clonic or Partial Onset Seizures focused on measuring Perampanel, Fycompa, Primary Generalized Tonic-Clonic Seizures, E2007-G000-332, E2007
Eligibility Criteria
Inclusion criteria:
- Participants who have completed their participation in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338, or who are being rolled over from EAP E2007-G000-401 and, who in the opinion of the treating physician, continue to demonstrate a positive benefit-to-risk ratio from treatment with perampanel.
- Participants who provide informed consent where applicable per local requirements.
- Female participants 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 (example, a double-barrier method [condom plus spermicide, condom plus diaphragm with spermicide]).
Exclusion criteria:
- Participants who reside in countries where the appropriate formulation of perampanel is commercially available.
- Female participants who are nursing, pregnant, or planning to become pregnant.
Sites / Locations
- Cliniques Universitaires Saint-Luc
- Hôpital Universitaire des Enfants Reine Fabiola
- Centre Neurologique William Lennox
- Hospital Padre Hurtado
- Oy Neurodiagnostika Ap
- Tartu University Hospital
- Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet
- Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza
- Országos Idegsebészeti Tudományos Intézet
- Rajna és Fiai Kereskedelmi és Szolgáltató Kft.
- Servus Salvus Egeszsegugyi Szolgaltato Kft.
- Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház
- Pécsi Tudományegyetem
- Childrens University Hospital
- Klaipeda University Hospital
- Uniwersyteckie Centrum Kliniczne - PPDS
- NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
- Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
- Hospital Sant Joan de Deu
- Hospital Clinico San Carlos
- Hospital Universitario Virgen del Rocio -
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02307578
Brief Title
An Extended Access Program (EAP) for Perampanel
Official Title
An Extended Access Program (EAP) for Perampanel
Study Type
Expanded Access
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
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 main objective of this EAP is to ensure that participants participating in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401 continue to have access to perampanel until such time that the appropriate formulation of perampanel becomes commercially available in the country in which they reside or until no participants remain in the EAP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Generalized Tonic-Clonic or Partial Onset Seizures, Lennox Gastaut Syndrome
Keywords
Perampanel, Fycompa, Primary Generalized Tonic-Clonic Seizures, E2007-G000-332, E2007
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Perampanel
Other Intervention Name(s)
E2007, Fycompa
Intervention Description
Perampanel will be available in 2-milligrams (mg), 4-mg and 8-mg tablets and as 0.5 milligram per milliliter (mg/mL) oral suspension. Participants will start this EAP with the dose that they were receiving at the end of their participation in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401. Doses of perampanel can be adjusted based on clinical judgment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Eligibility Criteria
Inclusion criteria:
Participants who have completed their participation in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338, or who are being rolled over from EAP E2007-G000-401 and, who in the opinion of the treating physician, continue to demonstrate a positive benefit-to-risk ratio from treatment with perampanel.
Participants who provide informed consent where applicable per local requirements.
Female participants 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 (example, a double-barrier method [condom plus spermicide, condom plus diaphragm with spermicide]).
Exclusion criteria:
Participants who reside in countries where the appropriate formulation of perampanel is commercially available.
Female participants who are nursing, pregnant, or planning to become pregnant.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eisai Medical Information
Phone
1-888-274-2378
Email
esi_medinfo@eisai.com
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
Country
Belgium
Individual Site Status
Available
Facility Name
Hôpital Universitaire des Enfants Reine Fabiola
City
Brussels
Country
Belgium
Individual Site Status
Available
Facility Name
Centre Neurologique William Lennox
City
Ottignies
Country
Belgium
Individual Site Status
Available
Facility Name
Hospital Padre Hurtado
City
Santiago
Country
Chile
Individual Site Status
Available
Facility Name
Oy Neurodiagnostika Ap
City
Tallinn
Country
Estonia
Individual Site Status
Available
Facility Name
Tartu University Hospital
City
Tartu
Country
Estonia
Individual Site Status
Available
Facility Name
Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet
City
Budapest
Country
Hungary
Individual Site Status
Available
Facility Name
Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza
City
Budapest
Country
Hungary
Individual Site Status
Available
Facility Name
Országos Idegsebészeti Tudományos Intézet
City
Budapest
Country
Hungary
Individual Site Status
Available
Facility Name
Rajna és Fiai Kereskedelmi és Szolgáltató Kft.
City
Budapest
Country
Hungary
Individual Site Status
Available
Facility Name
Servus Salvus Egeszsegugyi Szolgaltato Kft.
City
Budapest
Country
Hungary
Individual Site Status
Available
Facility Name
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház
City
Miskolc
Country
Hungary
Individual Site Status
Available
Facility Name
Pécsi Tudományegyetem
City
Pécs
Country
Hungary
Individual Site Status
Available
Facility Name
Childrens University Hospital
City
Riga
Country
Latvia
Individual Site Status
Available
Facility Name
Klaipeda University Hospital
City
Klaipeda
Country
Lithuania
Individual Site Status
Available
Facility Name
Uniwersyteckie Centrum Kliniczne - PPDS
City
Gdansk
Country
Poland
Individual Site Status
Available
Facility Name
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
City
Kielce
Country
Poland
Individual Site Status
Available
Facility Name
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
City
Poznan
Country
Poland
Individual Site Status
Available
Facility Name
Hospital Sant Joan de Deu
City
Esplugues de Llobregat
Country
Spain
Individual Site Status
Available
Facility Name
Hospital Clinico San Carlos
City
Madrid
Country
Spain
Individual Site Status
Available
Facility Name
Hospital Universitario Virgen del Rocio -
City
Sevilla
Country
Spain
Individual Site Status
Available
12. IPD Sharing Statement
Learn more about this trial
An Extended Access Program (EAP) for Perampanel
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