Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT04144218
Status:
UNKNOWN
Last Update Posted:
2020-05-12
First Post:
2019-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy
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': 'D000078334', 'term': 'Lacosamide'}], 'ancestors': [{'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-09', 'studyFirstSubmitDate': '2019-10-17', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2020-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of weekly seizures (times/week)', 'timeFrame': '16-week', 'description': 'The reduction of absolute number of weekly seizures in the 16-week treatment period compared with the retrospective baseline period'}, {'measure': 'Assessment of liver function by serum alanine aminotransferase (U/L)', 'timeFrame': 'One year', 'description': 'The serum alanine aminotransferase (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the liver function of patients.'}, {'measure': 'Assessment of renal function by serum creatinine (umol/L)', 'timeFrame': 'One year', 'description': 'The serum creatinine (blood biochemistry) will be performed at baseline, at the 3rd and 6th visits to monitor the renal function of patients.'}, {'measure': 'Assessment of white blood cell count ( /L)', 'timeFrame': 'One year', 'description': 'The white blood cell count (blood routine) will be performed at baseline, at the 3rd and 6th visits to monitor the renal function of patients.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'Children with focal refractory epilepsy will be routinely included in the collection of history, blood routine, biochemistry, EEG, MRI and 18F-FDG PET to determine the location of the epileptogenic focus and to assess the severity of the disease. This international multicenter clinical trial uses a double-blind, randomized, controlled study to evaluate the safety and efficacy of LCM in clinical applications in children with epilepsy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of focal epilepsy with or without generalized seizures according to the 2017 International Association of Anti-Epilepsy (ILAE) classification criteria.\n* Stable taking 1 or 2 other first-line anti-epileptic drugs for at least 10 weeks before screening visits.\n* Seizure occurred during the 8-week retrospective baseline period with a complete medical record diary.\n\nExclusion Criteria:\n\n* A history of status epilepticus within 3 months prior to screening visits.\n* Poor adherence to previous treatment.\n* Other serious organic diseases, mental illnesses and neurological diseases.\n* Abnormal liver and kidney function and blood routine results.'}, 'identificationModule': {'nctId': 'NCT04144218', 'briefTitle': 'Evaluation of the Efficacy and Safety of Lacosamide in Pediatric Patients With Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'International Multicenter, Double-blind, Randomized, Placebo-controlled Evaluation of the Efficacy and Safety of Lacosamide in the Treatment of Pediatric Patients With Focal Refractory Epilepsy.', 'orgStudyIdInfo': {'id': 'IR20191016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Drug: Placebo oral tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'interventionNames': ['Drug: Lacosamide']}], 'interventions': [{'name': 'Lacosamide', 'type': 'DRUG', 'description': 'The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.', 'armGroupLabels': ['Experimental group']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Wang', 'role': 'CONTACT', 'email': 'wangjing5678@126.com', 'phone': '+86 057187767138'}], 'facility': 'Department of Nuclear Medicine and PET/CT Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Jing Wang', 'role': 'CONTACT', 'email': 'wangjing5678@126.com', 'phone': '+86 057187767138'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': 'Michigan State University', 'class': 'OTHER'}, {'name': 'Juntendo University', 'class': 'OTHER'}, {'name': 'Technical University of Munich', 'class': 'OTHER'}, {'name': 'RIKEN', 'class': 'OTHER'}, {'name': 'University of California, Los Angeles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}