Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.
Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms: a Double Blind Randomized Controlled Trail
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Previous 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.
MRI 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.
In this study, DMF was evaluated for its ability to reduce inflammation of the aneurysm wall measured with High-resolution Vessel Wall Imaging (HR-VWI).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100070
- Beijing Neurosurgical Institute & Beijing Tiantan Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or female aged ≥18 years.
- Unruptured IA of ≥3mm identified on imaging (CT, MRI or digital subtraction angiography).
- Aneurysm wall enhancement identified by HR-VWI before treatment.
- Ability to understand the objective of the trial with provision of written informed consent.
Exclusion Criteria:
- MRI contraindications (metallic implant, contrast allergy, claustrophobia, etc).
- Planned treatment of the aneurysm within 6 months.
- Current treatment with drugs that might have an anti-inflammatory effect (aspirin, statins, immunosuppressive drugs, angiotensin converting enzyme, etc.).
- Severely impaired liver or renal function.
- Retreatment of recurrent aneurysm.
- Pregnant or lactating women.
- Malignant diseases (liver disease, kidney disease, congestive heart failure, malignant tumours, etc.).
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dimethyl fumarate
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)
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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.
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Placebo Comparator: Placebo
placebo with the same appearance (color, taste, size, shape)
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placebo with the same appearance (color, taste, size, shape), 30 patients for this arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of aneurysm wall inflammation as measured by HR-VW-MRI.
Time Frame: 6 months
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At the end of 6 months, the changes of Wall enhancement index (WEI) and wall enhancement volume rate (WEVR) on HR-VW-MRI will be quantitatively compared between the DMF group and placebo group.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of aneurysmal morphology parameter
Time Frame: 6 months
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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.
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6 months
|
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Change of inflammatory markers in patients
Time Frame: 6 months
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Changes in CRP, TNF-α, IL-Iβ, IL-2R, IL-6, IL-8 and IL-10 in patients with unruptured IAs from before treatment to the 6 months follow-up.
The inflammatory markers levels will be measured at before treatment and at 6 months follow-up.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Yisen Zhang, MD, Beijing Neurosurgical Institute & Beijing Tiantan Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BTHDMF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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