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Completed
NCT05959759
Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.
Conditions: Intracranial Aneurysm, Aneurysm, Brain, Inflammation Vascular
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 60
Sponsor: Beijing Tiantan Hospital
Location: Beijing Neurosurgical Institute & Beijing Tiantan Hospital Beijing Beijing Municipality
Summary
This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate.
Eligibility Criteria
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 6 months.
3. Current treatment with drugs that might have an anti-inflammatory effect (aspirin, statins, immunosuppressive drugs, angiotensin converting enzyme, 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 with treatment or follow--up (patients who refuse to take medication as prescribed, patients who decline imaging follow--up or blood test, etc).
Source: ClinicalTrials.gov (NCT05959759). StuddyBuddy aggregates publicly available trial information.