Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-01-02 @ 1:39 AM
Study NCT ID:
NCT03852303
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2019-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ivermectin Treatment of Persons With Onchocerciasis-associated 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': 'D007559', 'term': 'Ivermectin'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 197}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2019-02-21', 'studyFirstSubmitQcDate': '2019-02-21', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'seizure freedom', 'timeFrame': 'month 9-12', 'description': 'no seizures'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months. The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.', 'detailedDescription': 'Randomized clinical trial in the Logo health zone, in Ituri province, Democratic Republic of Congo to compare seizure freedom in onchocerciasis infested epilepsy patients who ivermectin treatment once a year compared to 2 and 3 times a year. All participants also receive anti-epileptic drugs according to local guidelines for epilepsy treatment. Participants will be followed for 12 months.The primary endpoint is seizure freedom defined as no seizures during the last fourth months of the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 5 years and above\n* Signed informed consent form\n* Normal neurological development until onset of epilepsy\n* Onset of epilepsy between ages of 5 and 18 years\n* Presence of microfilaria in skin snip and/or antibodies against Ov16\n\nExclusion Criteria:\n\n* Ivermectin intake the last 9 months\n* Pregnancy or breastfeeding\n* Known or suspected allergy to Ivermectin\n* Loa Loa microfilariae in blood\n* Epilepsy with known cause (e.g. severe head trauma, perinatal asphyxia, patients with a history of cerebral malaria, meningitis or encephalitis)\n* Concomitant acute illness or chronic medication use\n* Chronic alcohol/substance use'}, 'identificationModule': {'nctId': 'NCT03852303', 'acronym': 'OAETREATe', 'briefTitle': 'Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'OAETREAT Extra Ivermectin Treatment of Persons With Onchocerciasis-associated Epilepsy: a', 'orgStudyIdInfo': {'id': 'B300201733349'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ivermectin once a year', 'description': 'Ivermectin one dose per year and anti-epileptic treatment', 'interventionNames': ['Drug: ivermectin']}, {'type': 'EXPERIMENTAL', 'label': 'ivermectin 2 times a year', 'description': 'Ivermectin one dose 2 times a year and anti-epileptic treatment', 'interventionNames': ['Drug: ivermectin']}, {'type': 'EXPERIMENTAL', 'label': 'ivermectin 3 times a year', 'description': 'vermectin one dose 3 times a year and anti-epileptic treatment', 'interventionNames': ['Drug: ivermectin']}], 'interventions': [{'name': 'ivermectin', 'type': 'DRUG', 'otherNames': ['anti-epileptic treatment'], 'description': 'evaluate effect of ivermectin on frequency of seizures', 'armGroupLabels': ['ivermectin 2 times a year', 'ivermectin 3 times a year', 'ivermectin once a year']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rethy', 'state': 'Ituri', 'country': 'Democratic Republic of the Congo', 'facility': "Centre de Recherche en Maladies Tropicales de l'Ituri", 'geoPoint': {'lat': 2.08634, 'lon': 30.89612}}], 'overallOfficials': [{'name': 'Robert Colebunders, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiteit Antwerpen'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After publication of results', 'ipdSharing': 'YES', 'description': 'A', 'accessCriteria': 'Approval of the PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Research Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Robert Colebunders', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}