Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT05497193
Status:
UNKNOWN
Last Update Posted:
2022-08-11
First Post:
2022-07-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}], 'ancestors': [{'id': 'D004827', 'term': 'Epilepsy'}, {'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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-08', 'studyFirstSubmitDate': '2022-07-26', 'studyFirstSubmitQcDate': '2022-08-08', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical efficacy after drug treatment:', 'timeFrame': 'one year', 'description': 'Epilepsy seizures: the seizure frequency 3 months before treatment is the baseline, and the maintenance period is compared with the baseline. Complete control: no seizures after treatment; markedly effective: seizure frequency reduced by \\> 75%; effective: seizure frequency reduced by \\> 51%-74 %; Ineffective: frequency reduced by ≤50%, worsening: attack frequency increased by 25%.'}, {'measure': 'EEG changes after drug treatment', 'timeFrame': 'one year', 'description': 'EEG changes: (1) normal EEG (2) abnormal EEG: including epileptiform discharge, background rhythm slowing, epileptiform discharge + background rhythm slowing. EEG judgment: (1) normal: the epileptiform discharge disappeared or the background slowing disappeared (2) effective: the epileptiform discharge was reduced or the background slowing was improved (3) invalid: the epileptiform discharge did not change or aggravate after the drug.'}, {'measure': 'safety after drug treatment', 'timeFrame': 'one year', 'description': 'Common adverse reactions include: dizziness, drowsiness, fatigue, irritability, nausea and falls and weight gain.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Focal Epilepsy']}, 'descriptionModule': {'briefSummary': 'This project is a multicenter prospective study. By retrieving outpatient medical records and collecting clinical data of epilepsy patients, the efficacy and safety of single-drug perampanel in patients with focal epilepsy were analyzed.', 'detailedDescription': 'This project is a multicenter prospective study. The selected case population was given the oral antiepileptic drug perampanel for 12 months, and the seizure control (complete control, markedly effective, effective, ineffective, worsening), EEG changes (normal, Effective, ineffective), and adverse reactions were analyzed, so as to provide a basis for perampanel monotherapy in children with focal epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in the pediatric outpatient department of our hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) Clinical diagnosis of focal epilepsy; (2) Take anti-epileptic drugs as prescribed by your doctor; (3) Epilepsy patients diagnosed with focal epilepsy with or without generalized seizures, and Monitoring for ≥12 months; (4) Newly diagnosed epilepsy patients, or only taking 1-2 other AEDs, without regular antiepileptic treatment, the efficacy is not good, after using perampanel, gradually stop AEDs for 8 weeks. For perampanel monotherapy; (5) the number of seizures ≥ 1 in the first 3 months of enrollment.\n\nExclusion Criteria:\n\n(1) syncope (2) Pseudo-seizure(3)transient ischemic attack'}, 'identificationModule': {'nctId': 'NCT05497193', 'briefTitle': 'Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Clinical Efficacy and Safety of Perampanel Monotherapy in the Treatment of Children With Focal Epilepsy', 'orgStudyIdInfo': {'id': '20222126'}}, 'armsInterventionsModule': {'interventions': [{'name': 'perampanel', 'type': 'DRUG', 'otherNames': ['No other interventions currently'], 'description': "China's state food and drug administration approved indications for adults and children aged 4 or more focal epileptic hair company or not with secondary comprehensive seizures of epilepsy, adding treatment, in July 2020 to monotherapy without clinical approval, the current domestic perampanel monotherapy clinical effectiveness and safety of focal epilepsy in children have not been reported."}]}, 'contactsLocationsModule': {'locations': [{'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': 'XI Jing Hospital', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'xinwei yang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'hospital doctor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yang Xinwei', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Deputy Chief Physician', 'investigatorFullName': 'Yang Xinwei', 'investigatorAffiliation': 'Xijing Hospital'}}}}