Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-20 @ 10:44 PM
Study NCT ID:
NCT02033902
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2013-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551441', 'term': 'perampanel'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-06', 'studyFirstSubmitDate': '2013-12-17', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Treatment Emergent Adverse Events (TEAEs) of interest', 'timeFrame': 'Up to 52 weeks and 2 weeks of follow-up', 'description': 'Assessment of events of dizziness, blurred vision, somnolence, aggression, balance disorders, ataxia, falls, unintended pregnancy, weight gain, suicidality, drug abuse, misuse, dependence, withdrawal, off-label use, skin photosensitivity, unintended pregnancy while taking levonorgestrel-containing contraceptives, and outcomes associated with any suspected drug-drug interaction.'}], 'secondaryOutcomes': [{'measure': 'Incidence of unintended pregnancy', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Incidence of off-label use', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Summary scores for the Hospital Anxiety and Depression Scale (HADS)', 'timeFrame': 'Screening, Week 52'}, {'measure': 'Number of TEAEs in the patient subpopulations of interest', 'timeFrame': 'Up to 52 weeks and 2 weeks of follow-up', 'description': 'TEAEs observed in the specified subpopulations of patients could also be made in order to get a better understanding of whether any of these particular potential risk factors (e.g., old age, cardiovascular disease) define groups with greater or lesser risk.'}, {'measure': 'Clinical Global Impression of Change', 'timeFrame': 'Week 52', 'description': 'Assessment of disease severity will utilize the Clinical Global Impression of Change (CGI-C) scale at end of treatment to evaluate change in disease status since initiation of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Epilepsy'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '35305920', 'type': 'DERIVED', 'citation': 'Maguire M. Response to "Perampanel and pregnancy: Could experience be a gloomy lantern that does not even illuminate its bearer?". Epilepsy Behav. 2022 Apr;129:108654. doi: 10.1016/j.yebeh.2022.108654. Epub 2022 Mar 16. No abstract available.'}, {'pmid': '34953337', 'type': 'DERIVED', 'citation': 'Maguire M, Ben-Menachem E, Patten A, Malhotra M, Ngo LY. A post-approval observational study to evaluate the safety and tolerability of perampanel as an add-on therapy in adolescent, adult, and elderly patients with epilepsy. Epilepsy Behav. 2022 Jan;126:108483. doi: 10.1016/j.yebeh.2021.108483. Epub 2021 Dec 23.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.', 'detailedDescription': 'This is a global, observational, cohort study in patients with epilepsy. Multiple treating physicians will prescribe perampanel to approximately 500 patients, who then will be observed for approximately 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Epilepsy patients prescribed adjunctive treatment in countries where perampanel has received marketing approval. Multiple treating physicians will prescribe perampanel to patients, who then will be observed for approximately 52 weeks.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Male or female patients age greater than or equal to 12 years (or as regionally appropriate) at the time of informed consent\n2. Patients prescribed perampanel for the adjunctive treatment of epilepsy within 7 days of the Screening Visit\n3. Patients who provide informed consent\n\nExclusion Criteria\n\n1. Participation in another study involving administration of an investigational drug or device whilst participating in this observational study\n2. Prior participation in a perampanel clinical study\n3. Hypersensitivity to perampanel'}, 'identificationModule': {'nctId': 'NCT02033902', 'briefTitle': 'A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years', 'orgStudyIdInfo': {'id': 'E2007-G000-402'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Perampanel', 'description': "Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment", 'interventionNames': ['Drug: Perampanel']}], 'interventions': [{'name': 'Perampanel', 'type': 'DRUG', 'description': "Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment", 'armGroupLabels': ['Perampanel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Universitatsklinikum Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Kepler Universitätsklinikum', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Krankenhaus Wien-Hietzing', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'city': 'Battice', 'country': 'Belgium', 'facility': 'Eisai Site# 2405', 'geoPoint': {'lat': 50.64734, 'lon': 5.82104}}, {'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Hôpital Erasme', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'Eisai Site# 2404', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Duffel', 'country': 'Belgium', 'facility': 'Eisai Site# 2406', 'geoPoint': {'lat': 51.09554, 'lon': 4.50903}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Uz Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'Eisai Site# 2409', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Ottignies', 'country': 'Belgium', 'facility': 'Eisai Site# 2403', 'geoPoint': {'lat': 50.66535, 'lon': 4.56679}}, {'city': 'Ruddershove', 'country': 'Belgium', 'facility': 'Eisai Site# 2408', 'geoPoint': {'lat': 50.88235, 'lon': 3.7606}}, {'city': 'Woluwe-Saint-Lambert', 'country': 'Belgium', 'facility': 'Eisai Site# 2407', 'geoPoint': {'lat': 50.84389, 'lon': 4.42912}}, {'city': 'Yvoir', 'country': 'Belgium', 'facility': 'Eisai Site# 2402', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'city': 'Beroun', 'country': 'Czechia', 'facility': 'Eisai Site# 2601', 'geoPoint': {'lat': 49.96382, 'lon': 14.072}}, {'city': 'Brno', 'country': 'Czechia', 'facility': 'Eisai Site# 2600', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Eisai Site# 2606', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'city': 'Náchod', 'country': 'Czechia', 'facility': 'Eisai Site# 2602', 'geoPoint': {'lat': 50.4167, 'lon': 16.16289}}, {'zip': '72200', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Cerebrovaskularni Poradna S.R.O.', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'city': 'Prague', 'country': 'Czechia', 'facility': 'Eisai Site# 2603', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Beersheba', 'country': 'Israel', 'facility': 'Eisai Site# 2013', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Center', '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': 'Jerusalem', 'country': 'Israel', 'facility': 'Kiryat Hadassah', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '4428164', 'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'zip': '22100', 'city': 'Nahariya', 'country': 'Israel', 'facility': 'Western Galilee Hospital', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'zip': '49202', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': "Schneider Children's Medical Center Of Israel", 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'The Chaim Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel-Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Eisai Site# 2003', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Eisai Site# 2012', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Eisai Site# 2008', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': 'SE-41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Sahlgrenska Universitetssjukhuset', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}, {'zip': '58185', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'Universitetssjukhuset I Linköping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Eisai Site# 1607', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'Dd1 9Sy', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Ninewells Hospital', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'city': 'Lincoln', 'country': 'United Kingdom', 'facility': 'Eisai Site# 1611', 'geoPoint': {'lat': 53.22683, 'lon': -0.53792}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Eisai Site# 1604', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Eisai Site# 1608', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Eisai Site# 1609', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Great Ormond Street hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'Eisai Site# 1612', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'city': 'Truro', 'country': 'United Kingdom', 'facility': 'Eisai Site# 1606', 'geoPoint': {'lat': 50.26526, 'lon': -5.05436}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}