Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 10:46 AM
Study NCT ID:
NCT05485558
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2022-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069279', 'term': 'Drug Resistant Epilepsy'}], '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': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'double blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-29', 'studyFirstSubmitDate': '2022-07-30', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effectivness of acetyl cysteine for controlling epileptic seizures in children with drug resistant epilepsy.', 'timeFrame': '6 months', 'description': 'effectivness can be defined as more than 50% reduction in number of seizures.'}], 'secondaryOutcomes': [{'measure': 'analyze the differences of improvement of quality of life via using Helth related quality of life questionnaire', 'timeFrame': '6 months', 'description': "Caregivers will complete the Quality of Life in Childhood Epilepsy (QOLCE) Scale(QOLCE-55).The QOLCE-55 sections' included the following domains: cognitive, emotional, social, and physical functioning Each item is on a 6-point Likert scale and includes anchors that are subjectively rated based on perceived QOL (e.g., 1 = very often, 2 = fairly often, 3 = sometimes, 4 = almost never, 5 = never, 6 = non-applicable).\n\nCaregivers completed the Quality of Life in Childhood Epilepsy (QOLCE) Scale.17"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['N-acetyl cysteine'], 'conditions': ['Drug Resistant Epilepsy']}, 'descriptionModule': {'briefSummary': 'This study aims at investigating the possible efficacy and safety of N-acetyl cysteine as adjuvant therapy in the treatment of drug-resistant epilepsy', 'detailedDescription': 'N-acetyl-cysteine (NAC), a glutathione precursor, is proven to activate the nuclear factor E2-related factor 2( Nrf2) in mouse models of status epilepticus, thus inhibiting high mobility group box 1 (HMGB1) cytoplasmic translocation in the hippocampal neural and glial cells and preventing the linkage between oxidative stress and neuroinflammation for which the redox-sensitive protein HMGB1 is central. Therefore,It may be useful as an adjuvant in treating various medical conditions, especially neuropsychiatry.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 3-18 years with intractable childhood-onset epilepsy.\n\n * All patients are diagnosed to have drug-resistant epilepsy (refractory epilepsy) according to the ILAE definition.\n * The subject is willing and able to comply with the study requirements\n\nExclusion Criteria:\n\n* Any metabolic conditions that might increase the risks associated with trial participation or investigational product administration, such as hepatic enzyme elevation greater than twice normal and/or a GFR \\< 60 mL/min/1.73 m2 or electrolyte imbalance.\n\n * Patients with Known allergy to N-acetyl cysteine.\n * Patients taking antioxidant and/or anti-inflammatory medications'}, 'identificationModule': {'nctId': 'NCT05485558', 'briefTitle': 'the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Clinical Study Evaluating the Safety and Efficacy of N-acetyl Cysteine in Children With Drug-Resistant Epilepsy', 'orgStudyIdInfo': {'id': 'NAC in DRE.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': '30 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'N-acetyl cysteine group', 'description': '30patients will receive 10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.', 'interventionNames': ['Drug: N-acetyl cysteine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'N-actyl cysteine group', 'description': '30 patients will receive 40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.', 'interventionNames': ['Drug: NAc']}], 'interventions': [{'name': 'N-acetyl cysteine', 'type': 'DRUG', 'otherNames': ['NAC'], 'description': '10 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.', 'armGroupLabels': ['N-acetyl cysteine group']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['control'], 'description': '15 patients will receive standard antiepileptic drug plus placebo capsules for 6 months.', 'armGroupLabels': ['Control group']}, {'name': 'NAc', 'type': 'DRUG', 'description': '40 mg/kg of N-acetyl cysteine capsules together with their standard antiepileptic drug for 6 months.', 'armGroupLabels': ['N-actyl cysteine group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'overallOfficials': [{'name': 'Ahmed kishk, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanta University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Clinical Pharmacy', 'investigatorFullName': 'Amira Roshdy', 'investigatorAffiliation': 'Tanta University'}}}}