Ignite Creation Date:
2025-12-24 @ 2:45 PM
Ignite Modification Date:
2026-03-10 @ 7:23 PM
Study NCT ID:
NCT05959759
Status:
UNKNOWN
Last Update Posted:
2023-07-25
First Post:
2023-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002532', 'term': 'Intracranial Aneurysm'}], 'ancestors': [{'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069462', 'term': 'Dimethyl Fumarate'}], 'ancestors': [{'id': 'D005650', 'term': 'Fumarates'}, {'id': 'D003998', 'term': 'Dicarboxylic Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patients with intracranial aneurysms will be numbered and randomly divided into two groups, 30 patients in each group, and seal them. Through blind method, one group will be given dimethyl fumarate enteric capsule (the initial dose is 120 mg twice a day, and after 7 days, the dose will be increased to the maintenance dose of 240 mg twice a day, for 6 months). The other group took placebo with the same appearance (color, taste, size, shape) as the test drug.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A total of 60 patients will be enrolled in this study. Randomly divide the patients into experimental group and placebo group according to 1:1 ratio.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-07-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-16', 'studyFirstSubmitDate': '2023-07-16', 'studyFirstSubmitQcDate': '2023-07-16', 'lastUpdatePostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of aneurysm wall inflammation as measured by HR-VW-MRI.', 'timeFrame': '6 months', 'description': 'Change of aneurysm wall enhancement index of at least 20% on HR-VM-MRI at the end of 6 months of dimethyl fumarate treatment, compared to no treatment.'}], 'secondaryOutcomes': [{'measure': 'Change of aneurysmal morphology parameter', 'timeFrame': '6 months', 'description': 'The proportion of morphological growth of aneurysms from before treatment to the 6 months follow-up. An increase ≥ 1mm in any diameter or the appearance of a daughter sac will be defined as growth in aneurysmal morphology.'}, {'measure': 'Change of inflammatory markers in patients', 'timeFrame': '6 months', 'description': 'Changes in CRP, TNF-α, IL-1β and IL-6 in patients with unruptured IAs from before treatment to the 6 months follow-up. The CRP, TNF-α, IL-1β and IL-6 levels will be measured at before treatment and at 6 months follow-up.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dimethyl Fumarate', 'High resolution magnetic resonance'], 'conditions': ['Intracranial Aneurysm', 'Aneurysm, Brain', 'Inflammation Vascular']}, 'referencesModule': {'references': [{'pmid': '38772883', 'type': 'DERIVED', 'citation': 'Huang J, Zhang Y, Turhon M, Zheng Z, Li W, Kang H, Wang C, Liu J, Jiang P. Dimethyl fumarate treatment for unruptured intracranial aneurysms: a study protocol for a double-blind randomised controlled trial. BMJ Open. 2024 May 21;14(5):e080333. doi: 10.1136/bmjopen-2023-080333.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate.', 'detailedDescription': 'Intracranial aneurysm (IA) is a common cerebrovascular disease and the main cause of nontraumatic subarachnoid hemorrhage. Once ruptured, it will cause a high mortality rate, and nearly half of the survivors will also have disabilities. After comparing surgical risk and rupture risk, a significant proportion of patients with intracranial aneurysms choose conservative observation.\n\nPrevious studies suggest that inflammation of aneurysmal wall is a high-risk factor of rupture. Dimethyl fumarate (DMF) acts as an anti-inflammatory agent by activating nuclear factor erythroid 2-related factor 2(Nrf2) and other pathways. Animal experiments found dimethyl fumarate reduces the formation and rupture of intracranial aneurysms.\n\nMRI High-resolution vessel wall imaging (HR-VWI) has become a valuable method to assess the Wall of unruptured intracranial aneurysms. Using HR-VWI, it may be possible to detect smaller or more subtle areas of signal enhancement and change, which may give a more precise understanding of the pathology.\n\nIn this study, DMF was evaluated for its ability to reduce inflammation of the aneurysm wall measured with High-resolution Vessel Wall Imaging (HR-VWI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female aged ≥18 years.\n2. Unruptured IA of ≥3mm identified on imaging (CT, MRI or digital subtraction angiography).\n3. Aneurysm wall enhancement identified by HR-VWI before treatment.\n4. Ability to understand the objective of the trial with provision of written informed consent.\n\nExclusion Criteria:\n\n1. MRI contraindications (metallic implant, contrast allergy, claustrophobia, etc).\n2. Planned treatment of the aneurysm within 12 months.\n3. Current treatment with drugs that might have an anti-inflammatory effect (aspirin, statins, immunosuppressive drugs, etc.).\n4. Severely impaired liver or renal function.\n5. Retreatment of recurrent aneurysm.\n6. Pregnant or lactating women.\n7. Malignant diseases (liver disease, kidney disease, congestive heart failure, malignant tumours, etc.).\n8. Poor compliance.'}, 'identificationModule': {'nctId': 'NCT05959759', 'briefTitle': 'Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms: a Double Blind Randomized Controlled Trail', 'orgStudyIdInfo': {'id': 'BTHDMF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dimethyl fumarate', 'description': 'dimethyl fumarate enteric capsule (the initial dose is 120 mg twice a day, and after 7 days, the dose will be increased to the maintenance dose of 240 mg twice a day, for 6 months)', 'interventionNames': ['Drug: Dimethyl fumarate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'placebo with the same appearance (color, taste, size, shape)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dimethyl fumarate', 'type': 'DRUG', 'description': 'dimethyl fumarate enteric capsule (the initial dose is 120 mg twice a day, and after 7 days, the dose will be increased to the maintenance dose of 240 mg twice a day, for 6 months), 30 patients for this arm.', 'armGroupLabels': ['Dimethyl fumarate']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'placebo with the same appearance (color, taste, size, shape), 30 patients for this arm.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100070', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yisen Zhang, MD', 'role': 'CONTACT', 'email': 'zhang-yisen@163.com', 'phone': '+86-15001232615'}, {'name': 'Jiliang Huang', 'role': 'CONTACT', 'email': 'linkgo@qq.com', 'phone': '+86-18829793414'}], 'facility': 'Beijing Neurosurgical Institute & Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yisen Zhang, MD', 'role': 'CONTACT', 'email': 'zhang-yisen@163.com', 'phone': '+86-15001232615'}], 'overallOfficials': [{'name': 'Yisen Zhang, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Neurosurgical Institute & Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'starting 6 months after publication', 'ipdSharing': 'YES', 'description': 'Data are available on reasonable request.', 'accessCriteria': 'Data are available on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Neurosurgical Institute', 'class': 'OTHER'}, {'name': 'Beijing Chao Yang Hospital', 'class': 'OTHER'}, {'name': "Henan Provincial People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}