Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-28 @ 11:51 AM
Study NCT ID:
NCT06089356
Status:
UNKNOWN
Last Update Posted:
2023-10-18
First Post:
2023-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Zolmitriptane as Prophylaxis for Chilhood Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077236', 'term': 'Topiramate'}, {'id': 'D014635', 'term': 'Valproic Acid'}], 'ancestors': [{'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D007661', 'term': 'Ketoses'}, {'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-13', 'studyFirstSubmitDate': '2023-10-13', 'studyFirstSubmitQcDate': '2023-10-13', 'lastUpdatePostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number and severity of migraine attacks', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Migraine']}, 'descriptionModule': {'briefSummary': 'zolmitriptane can be tried as prophylactic therapy of childhood migraine', 'detailedDescription': '90 children with migraine included in the study first group 30 received zolmitriptane second group 30 received topiramate third group 30 received valproate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nchildren with migraine -\n\nExclusion Criteria:\n\nthose who suffer from ischemic heart disease , or who have allergy to any of drugs used\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06089356', 'briefTitle': 'Zolmitriptane as Prophylaxis for Chilhood Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Zolmitriptane as Prophylactic Therapy Childhood Migraine', 'orgStudyIdInfo': {'id': 'Migraine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'zolmitriptane', 'description': 'zolmitriptane tablet daily', 'interventionNames': ['Drug: zolmitriptanee']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'topiramate', 'description': 'topiramate tablet daily', 'interventionNames': ['Drug: topiramate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'valproate', 'description': 'valproate once daily', 'interventionNames': ['Drug: Valproate']}], 'interventions': [{'name': 'zolmitriptanee', 'type': 'DRUG', 'otherNames': ['zolmitriptane tablet'], 'description': 'zolmitriptane tablet daily', 'armGroupLabels': ['zolmitriptane']}, {'name': 'topiramate', 'type': 'DRUG', 'otherNames': ['topiramate tablet'], 'description': 'topiramate once daily', 'armGroupLabels': ['topiramate']}, {'name': 'Valproate', 'type': 'DRUG', 'otherNames': ['Valproate tablet'], 'description': 'valproate once daily', 'armGroupLabels': ['valproate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'state': 'Kafrelsheikh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'abeer salamah, lecturer', 'role': 'CONTACT', 'phone': '0201009221243'}], 'facility': 'Kafrelsheikh University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'abeer salamah, ass prof', 'role': 'CONTACT', 'email': 'abeersalamah84@yahoo.com', 'phone': '00201009221243'}, {'name': 'abeer salamah, ass prof', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Abeer Salamah, ass prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'kafrelsheikh university- egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Sherief Abd-Elsalam', 'investigatorAffiliation': 'Tanta University'}}}}