Primary Generalized Tonic-Clonic or Partial Onset SeizuresNCT02307578
An Extended Access Program (EAP) for Perampanel
A study testing Perampanel in people with Primary Generalized Tonic-Clonic or Partial Onset Seizures and Lennox Gastaut Syndrome, run by Eisai Inc. at 27 sites in 10 countries.
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… Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Primary Generalized Tonic-Clonic or Partial Onset Seizures, Lennox Gastaut Syndrome
- What is being tested?
- Perampanel
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 27 sitesin 10 countries
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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]).
Who cannot join
- 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.
Trial locations and contacts
27 sites in 10 countries.
27 sites in 10 countries
Hungary7 sites
Dél-Pesti Centrumkórház Országos Hematológiai és Infektológiai Intézet
Budapest
Magyarorszagi Reformatus Egyhaz (MRE) Bethesda Gyermekkorhaza
Budapest
Országos Idegsebészeti Tudományos Intézet
Budapest
Rajna és Fiai Kereskedelmi és Szolgáltató Kft.
Budapest
Servus Salvus Egeszsegugyi Szolgaltato Kft.
Budapest
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház
Miskolc
Pécsi Tudományegyetem
Pécs
Poland5 sites
Uniwersyteckie Centrum Kliniczne - PPDS
Gdansk
Nzoz Novo-Med
Katowice
NZOZ Centrum Neurologii Dzieciecej i Leczenia Padaczki
Kielce
Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu
Poznan
Instytut Psychiatrii Neurologii
Warsaw
Belgium3 sites
Cliniques Universitaires Saint-Luc
Brussels
Hôpital Universitaire des Enfants Reine Fabiola
Brussels
Centre Neurologique William Lennox
Ottignies
Spain3 sites
Hospital Sant Joan de Deu
Esplugues de Llobregat
Hospital Clinico San Carlos
Madrid
Hospital Universitario Virgen del Rocio -
Seville
Czechia2 sites
Artroscan
Ostrava-Trebovice
Všeobecná fakultní nemocnice, Pragtis s.r.o
Prague
About this study
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.
- Being tested
- Perampanel
- Keywords
- Perampanel, Fycompa, Primary Generalized Tonic-Clonic Seizures, E2007-G000-332, E2007
- Medical subject headings
- Lennox Gastaut Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
Also called E2007, Fycompa
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Generalized Tonic-Clonic or Partial Onset SeizuresStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02307578
- Sponsor's protocol ID
- E2007-G000-409
- Status last verified
- Mar 2025
- First submitted
- 2 Dec 2014
- Last updated
- 15 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extended Access Program (EAP) for Perampanel
- ClinicalTrials.gov ID
- NCT02307578
- Acronym / sponsor ID
- E2007-G000-409
- Keywords
- Perampanel, Fycompa, Primary Generalized Tonic-Clonic Seizures, E2007-G000-332, E2007
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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]).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerampanelAlso: E2007, FycompaPerampanel 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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
Related trials for Primary Generalized Tonic-Clonic or Partial Onset Seizures
RecruitingObservational study
A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures
Partial-Onset Seizures, Primary Generalized Tonic-clonic Seizures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
27 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perampanel in people with Primary Generalized Tonic-Clonic or Partial Onset Seizures and Lennox Gastaut Syndrome, run by Eisai Inc. at 27 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Hungary, Poland, Belgium, Spain, Czechia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.