Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-02-03 @ 3:16 AM
Study NCT ID:
NCT01871233
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2020-04-16
First Post:
2013-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Extended Access Program for Perampanel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C551441', 'term': 'perampanel'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'statusVerifiedDate': '2020-03', 'lastUpdateSubmitDate': '2020-04-15', 'studyFirstSubmitDate': '2013-06-04', 'studyFirstSubmitQcDate': '2013-06-04', 'lastUpdatePostDateStruct': {'date': '2020-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-06', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['anti-epileptic drug', 'Extended Access Program', 'partial onset seizures', 'Perampanel'], 'conditions': ['Partial Onset Seizures']}, 'descriptionModule': {'briefSummary': '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:\n\n* Screening: The patient will start the program once the Screening assessments are completed and the patient is qualified for participation.\n* Treatment: Additional assessments, physical examinations, and dosage changes will be clinically determined by the treating physician.\n\nPatients 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.\n\nTreatment will be prescribed as long as clinically appropriate according to the judgement of the treating physician and the approved Summary of Product Characteristics (SmPC).\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Patients who provide informed consent where applicable per local requirements.\n* 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\\])\n\nExclusion Criteria:\n\n* Patients residing in countries where perampanel is commercially available for the treatment of POS\n* Female patients who are lactating, pregnant, or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT01871233', 'briefTitle': 'An Extended Access Program for Perampanel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'An Extended Access Program for Perampanel', 'orgStudyIdInfo': {'id': 'E2007-G000-401'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Perampanel', 'type': 'DRUG', 'otherNames': ['E2007'], 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5519FNF', 'city': 'Mendoza', 'state': 'Mendoza Province', 'country': 'Argentina', 'facility': 'Fundacion Cerebro Y Mente', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': 'C1221ADC', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospital General De Agudos José María Ramos Mejia', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Centro De Estudio Y Tratamiento De La Epilepsia Y Sueno - Cetes S.A.', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'city': 'Rosario', 'country': 'Argentina', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'city': 'San José Guaymallén', 'country': 'Argentina'}, {'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'VIC 3065', 'city': 'Fitzroy', 'country': 'Australia', 'facility': "St Vincent's Hospital Melbourne", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'city': 'Fitzroy', 'country': 'Australia', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': 'VIC 3081', 'city': 'Heidelberg', 'country': 'Australia', 'facility': 'Clinical Trials, Epilepsy Research Centre, Melbourne Brain Centre', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': 'VIC 3050', 'city': 'Parkville', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Victoria', 'country': 'Australia'}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Uz Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Edegem', 'country': 'Belgium', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Uz Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Ottignies', 'country': 'Belgium', 'geoPoint': {'lat': 50.66535, 'lon': 4.56679}}, {'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Albert', 'country': 'Canada', 'facility': 'Foothills Medical Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Center', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5B 1T9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Youthdale Treatment Centers', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Calgary', 'country': 'Canada', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'London, Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Puente Alto', 'country': 'Chile', 'geoPoint': {'lat': -33.61169, 'lon': -70.57577}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'Hospital Dr. Sótero Del Río', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Valdivia', 'country': 'Chile', 'facility': 'Hospital Base Valdivia Servicio De Neurología', 'geoPoint': {'lat': -39.81422, 'lon': -73.24589}}, {'city': 'Valdivia', 'country': 'Chile', 'geoPoint': {'lat': -39.81422, 'lon': -73.24589}}, {'zip': '656 91', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni Nemocnice U Sv. Anny V Brne', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Fakultni Nemocnice Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Ostrava', 'country': 'Czechia', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '150 06', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Fakultni Nemocnice V Motole', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Laagri', 'country': 'Estonia', 'geoPoint': {'lat': 59.35083, 'lon': 24.61418}}, {'zip': '10617', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'West Tallinn Central Hospital', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '13419', 'city': 'Tallinn', 'country': 'Estonia', 'facility': 'Oy Neurodiagnostika Ap', 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '13419', 'city': 'Tallinn', 'country': 'Estonia', 'facility': "Tallinn Children's Hospital", 'geoPoint': {'lat': 59.43696, 'lon': 24.75353}}, {'zip': '51014', 'city': 'Tartu', 'country': 'Estonia', 'facility': 'Tartu University Hospital', 'geoPoint': {'lat': 58.38062, 'lon': 26.72509}}, {'city': 'Vantaa', 'country': 'Finland', 'geoPoint': {'lat': 60.29414, 'lon': 25.04099}}, {'city': 'Greece', 'country': 'Greece'}, {'city': 'Kwai Chung', 'country': 'Hong Kong', 'geoPoint': {'lat': 22.36828, 'lon': 114.13877}}, {'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '78278', 'city': 'Ashkelon', 'country': 'Israel', 'facility': 'Barzilai Medical Center', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Haifa', 'country': 'Israel', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '58100', 'city': 'Holon', 'country': 'Israel', 'facility': 'Edith Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'city': 'Netanya', 'country': 'Israel', 'geoPoint': {'lat': 32.33291, 'lon': 34.85992}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Federico Ii', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'country': 'Italy', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Prague', 'country': 'Latvia'}, {'zip': 'Lv-1004', 'city': 'Riga', 'country': 'Latvia', 'facility': 'Childrens Clinical University Hospital', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'city': 'Riga', 'country': 'Latvia', 'geoPoint': {'lat': 56.946, 'lon': 24.10589}}, {'zip': 'Lv 4201', 'city': 'Valmiera', 'country': 'Latvia', 'facility': "Outpatient Clinic 'Valmieras Veselibas Centrs'", 'geoPoint': {'lat': 57.54108, 'lon': 25.42751}}, {'zip': 'Lt-50009', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Hospital Of Lithuanian University Of Health Sciences Kaunas Clinics', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'city': 'Kaunas', 'country': 'Lithuania', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': 'Lt-92288', 'city': 'Klaipėda', 'country': 'Lithuania', 'facility': 'Klaipeda University Hospital', 'geoPoint': {'lat': 55.7068, 'lon': 21.13912}}, {'zip': 'Lt-08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Vilnius University Hospital Santariskes Clinics', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Petaling Jaya', 'country': 'Malaysia', 'geoPoint': {'lat': 3.10726, 'lon': 101.60671}}, {'city': 'Haarlem', 'country': 'Netherlands', 'geoPoint': {'lat': 52.38084, 'lon': 4.63683}}, {'zip': '5591', 'city': 'Heeze', 'country': 'Netherlands', 'facility': 'Kempenhaeghe', 'geoPoint': {'lat': 51.3828, 'lon': 5.57145}}, {'zip': '2130', 'city': 'Hoofddorp', 'country': 'Netherlands', 'facility': 'Stichting Epilepsie Instellingen Nederland', 'geoPoint': {'lat': 52.3025, 'lon': 4.68889}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Akademickie Centrum Kliniczne - Szpital Akademii Medycznej W Gdansku', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Gdansk', 'country': 'Poland', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Albacete', 'country': 'Spain', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}, {'zip': '18012', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario San Cecilio', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Granada', 'country': 'Spain', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari I Politècnis La Fe Bulevar Sur', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Dawan', 'country': 'Taiwan', 'geoPoint': {'lat': 23.20917, 'lon': 120.18722}}, {'city': 'Tainan', 'country': 'Taiwan', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'King Chulalongkorn Memorial Hospital, Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Phramongkutklao Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Bangplee', 'country': 'Thailand'}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Maharaj Nakorn Chiang Mai, Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '40002', 'city': 'Khonkaen', 'country': 'Thailand', 'facility': 'Srinagarind Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}