Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-03 @ 6:51 PM
Study NCT ID:
NCT03208660
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2017-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C551441', 'term': 'perampanel'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-10', 'studyFirstSubmitDate': '2017-07-03', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2019-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants remaining on Fycompa treatment at specified time points after initiation of treatment (Retention rate)', 'timeFrame': '3, 6, 12, 18, and 24 months', 'description': 'Retention rate is the ratio of the number of participants remaining on Fycompa treatment to the number of participants who could have been exposed for that length of time.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with a 50% response rate', 'timeFrame': 'up to 24 months', 'description': 'The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.'}, {'measure': 'Number of participants with a 75% response rate', 'timeFrame': 'up to 24 months', 'description': 'The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.'}, {'measure': 'Number of participants with a 100% response rate', 'timeFrame': 'up to 24 months', 'description': 'The response rate will be evaluated from seizure frequencies recorded in medical records or seizure diaries, where available. If not available, the investigator assessment of the therapeutic response will be used.'}, {'measure': 'Categorized percent reduction in seizure frequency from baseline', 'timeFrame': 'Baseline, up to 24 months', 'description': 'An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).'}, {'measure': 'Median percent change in seizure frequency from baseline', 'timeFrame': 'Baseline, up to 24 months', 'description': 'An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).'}, {'measure': 'Percentage of participants who had no change or a worsening of seizures from baseline', 'timeFrame': 'Baseline, up to 24 months', 'description': 'An epileptic seizure or seizure is a brief episode of signs or symptoms due to abnormal excessive or synchronous neuronal activity in the brain. The outward effect can vary from uncontrolled jerking movement (tonic-clonic seizure) to as subtle as a momentary loss of awareness (absence seizure).'}, {'measure': 'Total provider health care visits before, during, and after final dose of Fycompa', 'timeFrame': '6 months before initiation of Fycompa to 6 months after last dose of Fycompa', 'description': 'Total provider health care visits before, during, and after final dose of Fycompa will be summarized as a safety variable.'}, {'measure': 'Number of participants with any treatment-emergent (TE) serious adverse event (SAE) resulting in discontinuation of Fycompa', 'timeFrame': 'Up to 24 months', 'description': 'An SAE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the adverse events \\[AE\\] as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.'}, {'measure': 'Number of participants with any treatment-emergent adverse event (TEAE) resulting in discontinuation of Fycompa', 'timeFrame': 'Up to 24 months', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A TEAE is defined as an AE that emerges during treatment, having been absent at pretreatment (baseline) or (1) reemerges during treatment, having been present at pretreatment (baseline) but stopped before treatment, or (2) worsens in severity during treatment relative to the pretreatment state, when the AE is continuous.'}, {'measure': 'Mean change in body weight from baseline', 'timeFrame': 'Baseline, Up to 24 months', 'description': 'Change from baseline is calculated as the post-baseline value minus the baseline value.'}, {'measure': 'Mean change in height of pediatric participants from baseline', 'timeFrame': 'Baseline, Up to 24 months', 'description': 'Change from baseline is calculated as the post-baseline value minus the baseline value.'}, {'measure': 'Maximum dose of Fycompa', 'timeFrame': 'Up to 24 months', 'description': 'The extent of exposure of Fycompa will be determined by summarizing the maximum dose of the study drug.'}, {'measure': 'Average dose of Fycompa', 'timeFrame': 'Up to 24 months', 'description': 'The extent of exposure of Fycompa will be determined by summarizing the average dose of the study drug.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['seizure', 'Fycompa'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '35453064', 'type': 'DERIVED', 'citation': 'Segal E, Wheless J, Moretz K, Penovich P, Patten A, Malhotra M. Perampanel in real-world clinical care of adolescent and adult patients with epilepsy: Results from the retrospective Phase IV PROVE Study. Seizure. 2022 May;98:87-94. doi: 10.1016/j.seizure.2022.02.011. Epub 2022 Feb 26.'}, {'pmid': '34994582', 'type': 'DERIVED', 'citation': 'Segal E, Moretz K, Wheless J, Penovich P, Lancman M, Patten A, Malhotra M. PROVE-Phase IV Study of Perampanel in Real-World Clinical Care of Patients with Epilepsy: Interim Analysis in Pediatric Patients. J Child Neurol. 2022 Mar;37(4):256-267. doi: 10.1177/08830738211047665. Epub 2022 Jan 7.'}, {'pmid': '34942053', 'type': 'DERIVED', 'citation': 'Wechsler RT, Wheless J, Zafar M, Huesmann GR, Lancman M, Segal E, Chez M, Aboumatar S, Patten A, Salah A, Malhotra M. PROVE: Retrospective, non-interventional, Phase IV study of perampanel in real-world clinical care of patients with epilepsy. Epilepsia Open. 2022 Jun;7(2):293-305. doi: 10.1002/epi4.12575. Epub 2022 Mar 20.'}, {'pmid': '33681651', 'type': 'DERIVED', 'citation': 'Wheless J, Wechsler RT, Lancman M, Aboumatar S, Patten A, Malhotra M. Perampanel in real-world clinical care of patients with epilepsy: Interim analysis of a phase IV study. Epilepsia Open. 2020 Dec 19;6(1):79-89. doi: 10.1002/epi4.12445. eCollection 2021 Mar.'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Data will be obtained by reviewing the medical records of the participants with a diagnosis of epilepsy and treated with Fycompa on clinician's recommendation at up to approximately 40 epilepsy centers.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must have met all of the following criteria to be included in this study:\n\n 1. Diagnosis of epilepsy\n 2. Initiated treatment with Fycompa at any time after 01 Jan 2014\n 3. Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records (if required by an Institutional Review Board \\[IRB\\] or Independent Ethics Committee \\[IEC\\], or by regulatory authorities).\n\nExclusion Criteria:\n\n* Not applicable"}, 'identificationModule': {'nctId': 'NCT03208660', 'briefTitle': 'Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Retrospective Multicenter Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy', 'orgStudyIdInfo': {'id': 'E2007-G000-506'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fycompa', 'description': 'Participants diagnosed with epilepsy and treated with Fycompa', 'interventionNames': ['Drug: Fycompa']}], 'interventions': [{'name': 'Fycompa', 'type': 'DRUG', 'otherNames': ['Perampanel'], 'description': 'Oral suspension', 'armGroupLabels': ['Fycompa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Age Reversal & Neurology Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Bronislava Shafran, MD, PC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner - University Medical Center Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Neurological Institute', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'The University of Arizona Department of Neurology', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93636', 'city': 'Madera', 'state': 'California', 'country': 'United States', 'facility': "Valley Children's Hospital", 'geoPoint': {'lat': 36.96134, 'lon': -120.06072}}, {'zip': '95814', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Health', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs Neurological Associates', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33486', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'Boca Raton Regional Hospital', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33818', 'city': 'Lakeland', 'state': 'Florida', 'country': 'United States', 'facility': 'Capernaum Medical Center', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': "Nicklaus Children's Hospital", 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Hospital", 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32819', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Pediatric Neurology PA', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34233', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Doctors hospital of Sarasota', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Intercoastal Medical Group', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Meridian Clinical Research', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '83702', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Consultants in Epilepsy & Neurology PLLC', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Foundation Hospital', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '46804', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Neurological Center', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Mid-Atlantic Epilepsy and Sleep Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health Medical Group', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minnesota Epilepsy Group', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Northeast Regional Epilepsy Group', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '10530', 'city': 'Hartsdale', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 41.01899, 'lon': -73.79819}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19141', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Albert Einstein Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pennsylvania', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "Le Bonheur Children's Hospital - PIN", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Epilepsy Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98001', 'city': 'Auburn', 'state': 'Washington', 'country': 'United States', 'facility': 'Auburn Neurological Institute', 'geoPoint': {'lat': 47.30732, 'lon': -122.22845}}, {'zip': '98002', 'city': 'Auburn', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Neurology & Electrodiagnostic Center', 'geoPoint': {'lat': 47.30732, 'lon': -122.22845}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital - PIN", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405-4048', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Institute for Research and Innovation', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}