An Extended Access Program (EAP) for Perampanel

Lennox Gastaut Syndrome Clinical Trial

Official title:

An Extended Access Program (EAP) for Perampanel

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT02307578
• Other study ID #: E2007-G000-409
• Status: Available

Study information

• Verified date: May 2023
• Source: Eisai Inc.
• Contact: Eisai Medical Information
• Phone: 1-888-274-2378
• Email: esi_medinfo[@]eisai.com
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion criteria:

1. 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.

2. Participants who provide informed consent where applicable per local requirements.

3. 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:

1. Participants who reside in countries where the appropriate formulation of perampanel is commercially available.

2. Female participants who are nursing, pregnant, or planning to become pregnant.

Related Conditions & MeSH terms

• Lennox Gastaut Syndrome
• Primary Generalized Tonic-Clonic or Partial Onset Seizures
• Seizures

Intervention

Drug:
• Perampanel
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.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	Hôpital Universitaire des Enfants Reine Fabiola	Brussels
Belgium	Centre Neurologique William Lennox	Ottignies
Chile	Hospital Padre Hurtado	Santiago
Estonia	Oy Neurodiagnostika Ap	Tallinn
Estonia	Tartu University Hospital	Tartu
Hungary	Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet	Budapest
Hungary	Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza	Budapest
Hungary	Országos Idegsebészeti Tudományos Intézet	Budapest
Hungary	Rajna és Fiai Kereskedelmi és Szolgáltató Kft.	Budapest
Hungary	Servus Salvus Egeszsegugyi Szolgaltato Kft.	Budapest
Hungary	Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház	Miskolc
Hungary	Pécsi Tudományegyetem	Pécs
Latvia	Childrens University Hospital	Riga
Lithuania	Klaipeda University Hospital	Klaipeda
Poland	Uniwersyteckie Centrum Kliniczne - PPDS	Gdansk
Poland	NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki	Kielce
Poland	Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu	Poznan
Spain	Hospital Sant Joan de Deu	Esplugues de Llobregat
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Virgen del Rocio -	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Countries where clinical trial is conducted

Belgium,  Chile,  Estonia,  Hungary,  Latvia,  Lithuania,  Poland,  Spain,