Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms: a Double Blind Randomized Controlled Trail

BTHDMF

This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate.

2023-07-31

2023-12-31

2024-06-01

Not yet recruiting

Early phase I

60

Inclusion Criteria: 1. Male or female aged ≥18 years. 2. Unruptured IA of ≥3mm identified on imaging (CT, MRI or digital subtraction angiography). 3. Aneurysm wall enhancement identified by HR-VWI before treatment. 4. Ability to understand the objective of the trial with provision of written informed consent. Exclusion Criteria: 1. MRI contraindications (metallic implant, contrast allergy, claustrophobia, etc). 2. Planned treatment of the aneurysm within 12 months. 3. Current treatment with drugs that might have an anti-inflammatory effect (aspirin, statins, immunosuppressive drugs, etc.). 4. Severely impaired liver or renal function. 5. Retreatment of recurrent aneurysm. 6. Pregnant or lactating women. 7. Malignant diseases (liver disease, kidney disease, congestive heart failure, malignant tumours, etc.). 8. Poor compliance.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', '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.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

2023-07-25