Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-02 @ 11:36 AM
Study NCT ID:
NCT05131295
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2021-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D020301', 'term': 'Vasospasm, Intracranial'}, {'id': 'D000783', 'term': 'Aneurysm'}], 'ancestors': [{'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003622', 'term': 'Dapsone'}, {'id': 'D000536', 'term': 'Aluminum Hydroxide'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017607', 'term': 'Aluminum Compounds'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients were randomly assigned using a computer-derived table to receive from admission to the 15th-day post-ictus an oral dose of 2.5 ml/24 hours of placebo (aluminum hydroxide suspension) or a dapsone suspension containing 100 mg (2.5 ml/24 hours). In patients with unpaired consciousness a nasogastric tube was used. Treatment was initiated during the first five days post-ictus and continued until day 15. All patients underwent aneurysm clipping by microsurgery or obliteration employing endovascular coils; postoperatively, both groups received the usual prophylaxis (which included oral nimodipine from admission until day 21 post-ictus, normovolemia, and dextran) and/or treatment (which included the use of vasogenic amines and, in refractory cases, cerebral intra-arterial administration of nimodipine) of cerebral vasospasm.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2009-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-10', 'studyFirstSubmitDate': '2021-10-29', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-12-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of clinically defined delayed cerebral ischemia', 'timeFrame': 'During the first 21 days post-ictus.', 'description': 'Development of focal neurological deficits or impaired consciousness with progression to stupor or coma, not explained by any other medical condition.'}], 'secondaryOutcomes': [{'measure': 'Clinical outcome at discharge and three months later', 'timeFrame': 'An average of 12 days after hospitalization and at three months follow up after discharge.', 'description': 'Evaluation of the clinical outcome using the modified Rankin Scale at discharge and three months follow up. Considering a cutoff point defined as favorable if lower or equal to 2 and an unfavorable if greater or equal to 3.'}, {'measure': 'Infarction incidence demonstrated by computerized tomography (CT).', 'timeFrame': 'An average of 12 days after hospitalization.', 'description': 'Appearance of a new localized hypodensity in a vascular distribution in the final CT prior to discharge, using validated arterial territory maps.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dapsone', 'Cerebral vasospasm', 'Delayed cerebral ischemia', 'Subarachnoid hemorrhage', 'Aneurysms', 'Neuroprotective effect'], 'conditions': ['Subarachnoid Hemorrhage', 'Brain Ischemia', 'Subarachnoid Hemorrhage, Aneurysmal', 'Aneurysmal Subarachnoid Hemorrhage', 'Delayed Cerebral Ischemia', 'Vasospasm, Cerebral']}, 'referencesModule': {'references': [{'pmid': '15146002', 'type': 'BACKGROUND', 'citation': 'Goddard AJ, Raju PP, Gholkar A. 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Glucose-6-phosphate dehydrogenase deficiency, chlorproguanil-dapsone with artesunate and post-treatment haemolysis in African children treated for uncomplicated malaria. Malar J. 2012 Jul 10;11:139. doi: 10.1186/1475-2875-11-139."}, {'pmid': '22027241', 'type': 'BACKGROUND', 'citation': 'Zhao J, Zhou D, Guo J, Ren Z, Zhou L, Wang S, Zhang Y, Xu B, Zhao K, Wang R, Mao Y, Xu B, Zhang X; Fasudil Aneurysmal Subarachnoid Hemorrhage Study Group. Efficacy and safety of fasudil in patients with subarachnoid hemorrhage: final results of a randomized trial of fasudil versus nimodipine. Neurol Med Chir (Tokyo). 2011;51(10):679-83. doi: 10.2176/nmc.51.679.'}]}, 'descriptionModule': {'briefSummary': "Dapsone is a drug that has been used clinically for several decades due to its anti-infective effect, making it widely available. Its neuroprotective effects have been found through its glutamate receptors antagonistic effect. Their main objective was to study the neuroprotective properties in patients with aneurysmal subarachnoid hemorrhage and high-risk factors for the development of cerebral vasospasm. Both the placebo and the dapsone used in this clinical trial were provided by the institution's neurochemistry laboratory.", 'detailedDescription': "A prospective, analytical, randomized, double-blinded, placebo-controlled clinical trial was realized. Participants suffering from aneurysmal subarachnoid hemorrhage (SAH), matching the inclusion criteria, were randomly assigned using a computer-derived table to receive from admission to the 15th day post-ictus an oral dose of placebo (aluminum hydroxide suspension) or a dapsone suspension containing 100mg per day. A nasogastric tube was used in participants with unpaired consciousness. All patients underwent aneurysm clipping or obliteration employing endovascular coils. Both groups received the standard of care (which included oral nimodipine from admission until the 21st post-ictal day, normovolemia, and dextran), and if required, vasogenic amines and/or cerebral intra-arterial administration of nimodipine in cases of cerebral vasospasm.\n\nThe participants' characteristics were assessed before the randomization process in both groups. The clinical severity was classified by the World Federation of Neurological Surgeons (WNFS), and the amount of subarachnoid blood on CT was evaluated using the Fisher scale. Patients were evaluated during their stay to look for the appearance of DCI and were followed for at least three months to evaluate their clinical outcome using the modified Rankin Scale (mRS). Severe adverse events such as methemoglobinemia and other less severe effects that forced treatment discontinuation were also assessed.\n\nData were analyzed according to a defined prospective plan. The primary endpoint was the incidence of DCI during the first 21 days post-SAH.\n\nThe projected sample size was 50 patients, guaranteeing a power of 80% (error β 0.2) to detect a statistically significant difference between placebo and dapsone with an accepted two-tailed α error of 0.05. The sample size was calculated assuming an incidence of DCI in the placebo group of 45% and the dapsone group of 10%, making a difference of 35% between groups.\n\nThe clinical outcome at three months and the presence of infarction on CT at patient discharge were analyzed as secondary outcomes.\n\nCategorical variable data is presented as incidences and compare groups using the χ2 test or Fisher's exact test (when any of the cells had less than five patients). Continuous variables are presented as means and standard deviation (SD). The statistical test for these variables was the Student's t-test or nonparametric tests such as the Mann-Whitney U test.\n\nStatistical significance with a p-value \\<0.05 was established and the SPSS statistical package (version 23.0) was used to perform the analysis."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants presented with aneurysmal subarachnoid hemorrhage.\n* Candidates to aneurysm occlusion.\n* Fisher scale grade III or IV.\n\nExclusion Criteria:\n\n* Known glucose-6-phosphate dehydrogenase (G6PD) deficiency.\n* Anemia at admission.\n* Known allergy to sulfones or sulfas.\n* Severe systemic disease (renal or hepatic failure).'}, 'identificationModule': {'nctId': 'NCT05131295', 'briefTitle': 'Dapsone Use in Patients With Aneurysmal Subarachnoid Hemorrhage.', 'organization': {'class': 'OTHER', 'fullName': 'El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez'}, 'officialTitle': 'Neuroprotective Effect of Dapsone in Patients With Aneurysmal Subarachnoid Hemorrhage: Prospective, Randomized, Double-Blinded, Placebo-Controlled, Clinical Trial', 'orgStudyIdInfo': {'id': '35/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dapsone', 'description': 'Besides the standard of care, those assigned to the dapsone group received orally 100mg (2.5 ml) of dapsone suspension daily, from the admission day until the 15th-day post-ictus.', 'interventionNames': ['Drug: Dapsone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Besides the standard of care, those assigned to the placebo group received orally 2.5 ml of aluminum hydroxide gel daily, from the admission day until the 15th-day post-ictus.', 'interventionNames': ['Drug: Aluminum Hydroxide Gel']}], 'interventions': [{'name': 'Dapsone', 'type': 'DRUG', 'description': 'Dapsone is a drug that has been used clinically for several decades due to its anti-infective effect. It has an anti-inflammatory effect due to its inhibitory action on neutrophils. Neuroprotective effects have been found experimentally with the use of dapsone, predominantly through its glutamate receptors antagonistic effect; these are the main receptors involved in neuronal excitotoxicity.', 'armGroupLabels': ['Dapsone']}, {'name': 'Aluminum Hydroxide Gel', 'type': 'DRUG', 'description': 'Aluminum Hydroxide Gel is an antacid that works quickly to lower the acid in the stomach', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14269', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Edgar Nathal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "No IPD plan to protect the participants' identity."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}