Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 7:10 PM
Study NCT ID:
NCT05274035
Status:
UNKNOWN
Last Update Posted:
2022-03-25
First Post:
2022-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-center RWS of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children
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': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-10', 'studyFirstSubmitDate': '2022-03-02', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '50% response rate of Perampanel', 'timeFrame': '6 months', 'description': 'Proportion of subjects who have at least 50% reduction in total seizure frequency during the Maintenance Period relative to the Baseline'}], 'secondaryOutcomes': [{'measure': 'Seizure-free rate of Perampanel', 'timeFrame': '6 months', 'description': 'Proportion of subjects who achieve seizure-free status for total seizure during the Maintenance Period'}, {'measure': 'Retention rate of Perampanel', 'timeFrame': '6 months', 'description': 'Percentage of subjects still using perampanel after the Maintenance Period'}, {'measure': 'Incidence of AEs and discontinuation [Safety and Tolerability]', 'timeFrame': '6 months', 'description': 'Incidence of all of adverse events (AEs), serious adverse events (SAEs) and discontinuation from treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epilepsy', 'Perampanel'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': "This study is a multi-center, real-word clinical trial. The purpose of this study is to evaluate the safety and effectiveness of perampanel as an add-on treatment for epileptic seizure, and to find the effective maintenance and maximum dose in Chinese children. The enrolled subjects were epilepsy patients between 2 and 12 years of age who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed additional treatment. The study was a real-world prospective clinical study, and the initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation.", 'detailedDescription': "This is a multi-center, prospective, observational study. Subjects who meet all of the inclusion and none of the exclusion criteria will be received perampanel. Baseline seizure counts (frequency) data is collected by subjects or guardian/legally authorized representative, retrospectively.\n\nIt is expected to enroll 1000 patients with epilepsy who are eligible for inclusion enrollment and receiving Perampenal from July 2021 to November 2021. The initial and maximum doses of perampanel were individualized by neurologists according to the patient's clinical situation. The patients were followed up for 6 months and recorded the frequency of seizures and self-assessment of improvement. Safety will be assessed by monitoring and recording of all of AEs and serious adverse events (SAEs), discontinuation during 6 months treatment (patient spontaneous reporting)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'epilepsy patients between 2 and 12 years of age who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed additional treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥2y, ≤12y;\n* Within 3 months before taking perampanel, the frequency of epileptic seizures was ≥1 time/month on average;\n* 1-3 kinds of AEDs have been used, and the optimal dose and course of treatment have been reached, but the effect is not good. Perampanel is used as an additional treatment.\n\nExclusion Criteria:\n\n* Patients who have participated in other researches on antiepileptic drugs or medical devices;\n* Inaccurate or unreliable clinical records according to the judgment of participating doctors;\n* When the database is closed, the expected follow-up time is less than 6 months.'}, 'identificationModule': {'nctId': 'NCT05274035', 'briefTitle': 'A Multi-center RWS of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children', 'organization': {'class': 'OTHER', 'fullName': "Beijing Children's Hospital"}, 'officialTitle': 'A Multi-center, Real-world Clinical Study of Perampanel as an add-on Treatment for Epileptic Seizures in Chinese Children', 'orgStudyIdInfo': {'id': 'BCHsjk-2021-E-108-Y'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Perampanel', 'description': 'Epilepsy patients who had failed clinical treatment with 1-3 anti-epileptic drugs (AEDs) with the optimal dose and course of treatment and needed perampanel additional treatment.', 'interventionNames': ['Drug: Perampanel']}], 'interventions': [{'name': 'Perampanel', 'type': 'DRUG', 'otherNames': ['Fycompa'], 'description': 'For children ≥4 years old, the initial dose is 2 mg per day, the titration interval is ≥2 weeks, the daily dose is increased by 2 mg each time (based on clinical response and tolerability), and the maintenance dose is ≥4 mg per day, up to a maximum dose of 12 mg per day.\n\nFor children \\<4 years old, the initial dose is 0.04 mg/kg per day, the titration interval is ≥ 2 weeks, the daily dose is increased by 0.04 mg/kg each time (based on clinical response and tolerability), and the maintenance dose is ≥ 0.08 mg/day per day kg, the highest dose is 0.24 mg/kg per day.\n\nAccording to the actual clinical situation, the initial dose and addition plan are judged by the investigator.', 'armGroupLabels': ['Perampanel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100045', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Beijing Children's Hospital, Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '430015', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': "Wuhan Children's Hospital, Tongji Medical College of Huazhong University of Science and Technology", 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '221002', 'city': 'Xuzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "XuZhou Children's Hospital", 'geoPoint': {'lat': 34.20442, 'lon': 117.28386}}, {'zip': '250022', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': "Jinan Children's Hospital", 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '300134', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': "Tianjin Children's Hospital", 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Fang Fang', 'role': 'STUDY_CHAIR', 'affiliation': "Beijing Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiaodan Li, MD', 'investigatorAffiliation': "Beijing Children's Hospital"}}}}