Partial Onset SeizuresNCT01871233
An Extended Access Program for Perampanel
A study testing Perampanel in people with Partial Onset Seizures, run by Eisai Inc. at 78 sites in 21 countries.
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… Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Partial Onset Seizures
- What is being tested?
- Perampanel
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 78 sitesin 21 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 12 to 70 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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])
Who cannot join
- 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
Trial locations and contacts
78 sites in 21 countries.
78 sites in 21 countries
Spain8 sites
Study site
Albacete
Hospital Universitario San Cecilio
Granada, 18012
Study site
Granada
Fundacion Jimenez Diaz
Madrid, 28040
Hospital Clinico San Carlos
Madrid, 28040
Study site
Madrid
Hospital Universitari I Politècnis La Fe Bulevar Sur
Valencia, 46026
Study site
Valencia
Argentina7 sites
Hospital General De Agudos José María Ramos Mejia
Buenos Aires, C1221ADC
Study site
Buenos Aires
Centro De Estudio Y Tratamiento De La Epilepsia Y Sueno - Cetes S.A.
Córdoba
Fundacion Cerebro Y Mente
Mendoza, Mendoza Province, M5519FNF
Study site
Rosario
Study site
San José Guaymallén
Study site
San Miguel de Tucumán
Australia5 sites
St Vincent's Hospital Melbourne
Fitzroy, VIC 3065
Study site
Fitzroy
Clinical Trials, Epilepsy Research Centre, Melbourne Brain Centre
Heidelberg, VIC 3081
Royal Melbourne Hospital
Parkville, VIC 3050
Study site
Victoria
Belgium5 sites
Uz Antwerpen
Edegem, 2650
Study site
Edegem
Uz Gent
Ghent, 9000
Study site
Ghent
Study site
Ottignies
Canada5 sites
Foothills Medical Center
Calgary, Albert, T2N 2T9
Study site
Calgary
London Health Sciences Center
London, Ontario, N6A 5A5
Study site
London, Ontario
Youthdale Treatment Centers
Toronto, Ontario, M5B 1T9
Chile5 sites
Study site
Puente Alto
Hospital Dr. Sótero Del Río
Santiago
Study site
Santiago
Hospital Base Valdivia Servicio De Neurología
Valdivia
Study site
Valdivia
Estonia5 sites
Study site
Laagri
West Tallinn Central Hospital
Tallinn, 10617
Oy Neurodiagnostika Ap
Tallinn, 13419
Tallinn Children's Hospital
Tallinn, 13419
Tartu University Hospital
Tartu, 51014
Israel5 sites
Barzilai Medical Center
Ashkelon, 78278
Rambam Medical Center
Haifa, 31096
Study site
Haifa
Edith Wolfson Medical Center
Holon, 58100
Study site
Netanya
Thailand5 sites
King Chulalongkorn Memorial Hospital, Chulalongkorn University
Bangkok, 10330
Phramongkutklao Hospital
Bangkok, 10400
Study site
Bangplee
Maharaj Nakorn Chiang Mai, Chiang Mai University
Chiang Mai, 50200
Srinagarind Hospital
Khonkaen, 40002
Czechia4 sites
Fakultni Nemocnice U Sv. Anny V Brne
Brno, 656 91
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05
Study site
Ostrava
Fakultni Nemocnice V Motole
Prague, 150 06
Latvia4 sites
Study site
Prague
Childrens Clinical University Hospital
Riga, Lv-1004
Study site
Riga
Outpatient Clinic 'Valmieras Veselibas Centrs'
Valmiera, Lv 4201
Lithuania4 sites
Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics
Kaunas, Lt-50009
Study site
Kaunas
Klaipeda University Hospital
Klaipėda, Lt-92288
Vilnius University Hospital Santariskes Clinics
Vilnius, Lt-08661
Netherlands3 sites
Study site
Haarlem
Kempenhaeghe
Heeze, 5591
Stichting Epilepsie Instellingen Nederland
Hoofddorp, 2130
Italy2 sites
Azienda Ospedaliera Universitaria Federico Ii
Naples, 80131
Study site
Naples
Malaysia2 sites
University Malaya Medical Centre
Kuala Lumpur, 59100
Study site
Petaling Jaya
Poland2 sites
Akademickie Centrum Kliniczne - Szpital Akademii Medycznej W Gdansku
Gdansk, 80-952
Study site
Gdansk
About this study
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.
Read more
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.
- Conditions
- Partial Onset Seizures
- Being tested
- Perampanel
- Keywords
- anti-epileptic drug, Extended Access Program, partial onset seizures, Perampanel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerampanelDrug
Also called E2007
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- NCT01871233
- Sponsor's protocol ID
- E2007-G000-401
- Status last verified
- Mar 2020
- First submitted
- 4 Jun 2013
- Last updated
- 16 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extended Access Program for Perampanel
- ClinicalTrials.gov ID
- NCT01871233
- Acronym / sponsor ID
- E2007-G000-401
- Conditions
- Partial Onset Seizures
- Keywords
- anti-epileptic drug, Extended Access Program, partial onset seizures, Perampanel
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- First posted
- 6 Jun 2013 (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 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.
Study design
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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])
Key exclusion criteria (2 listed)
- 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
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: E2007Patients 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. | 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 16 Apr 2020.
Related trials for Partial Onset Seizures
RecruitingPhase 3
A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
Partial Epilepsy
Active, not recruiting
A Pilot Study: Focused Ultrasound Thalamotomy for the Prevention of Secondary Generalization in Focal Onset Epilepsy
Partial Seizures With Secondary Generalization, Focal Epilepsy With Secondary Generalization
RecruitingPhase 2
RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset Seizures
Focal Onset Seizures
Active, not recruitingPhase 2/3
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy
Focal Epilepsy
Not yet recruitingPhase 4
Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures
Seizures, Seizures, Focal
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.
78 sites in 21 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perampanel in people with Partial Onset Seizures, run by Eisai Inc. at 78 sites in 21 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 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 sites in Spain, Argentina, Australia, Belgium, Canada and 16 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 16 Apr 2020.