Intracranial AneurysmPhase 4NCT05959759
Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.
A Phase 4 study testing Dimethyl fumarate in people with Intracranial Aneurysm and Aneurysm, Brain, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm, Aneurysm, Brain, Inflammation Vascular
- What is being tested?
- Dimethyl fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2023to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Neurosurgical Institute & Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
About this study
Official title: Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms: a Double Blind Randomized Controlled Trail
This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate.
Read the 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).
- Being tested
- Dimethyl fumarate, Placebo
- Keywords
- Dimethyl Fumarate, High resolution magnetic resonance
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyl fumarateDrug
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.
PlaceboDrug
placebo with the same appearance (color, taste, size, shape), 30 patients for this arm.
| Study group | Role | What they receive |
|---|---|---|
| Dimethyl fumarate | Experimental | 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) Receives: Drug: Dimethyl fumarate |
| Placebo | Placebo comparator | placebo with the same appearance (color, taste, size, shape) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of aneurysm wall inflammation as measured by HR-VW-MRI.
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.
Measured: 6 months
Secondary outcomes (2)
Change of aneurysmal morphology parameter
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.
Measured: 6 months
Change of inflammatory markers in patients
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start31 Jul 2023
- Primary completion31 Dec 2025
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Neurosurgical Institute, Beijing Chao Yang Hospital, Henan Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Yisen Zhang, MD, Study director, Beijing Neurosurgical Institute & Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959759
- Sponsor's protocol ID
- BTHDMF
- Status last verified
- Dec 2025
- First submitted
- 16 Jul 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available on reasonable request.
Publications
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.
PubMed 38772883
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms: a Double Blind Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05959759
- Acronym / sponsor ID
- BTHDMF
- Keywords
- Dimethyl Fumarate, High resolution magnetic resonance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Neurosurgical Institute, Beijing Chao Yang Hospital, Henan Provincial People's Hospital
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to identify whether there is a measurable reduction in inflammation in walls of intracranial aneurysms with oral dimethyl fumarate.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dimethyl fumarate | Experimental | Drug: Dimethyl fumaratedimethyl 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) |
| Placebo | Placebo comparator | Drug: Placeboplacebo with the same appearance (color, taste, size, shape) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimethyl fumaratedimethyl 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. | Drug | Dimethyl fumarate |
| Placeboplacebo with the same appearance (color, taste, size, shape), 30 patients for this arm. | Drug | Placebo |
Primary outcome
Change of aneurysm wall inflammation as measured by HR-VW-MRI.
Time frame: 6 months
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.
2 secondary outcomes
Change of aneurysmal morphology parameter
Time frame: 6 months
Change of inflammatory markers in patients
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 38772883Huang 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.
- Individual participant dataSharing planned: Yes. Data are available on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yisen Zhang, MD study director
Beijing Neurosurgical Institute & Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dimethyl fumarate in people with Intracranial Aneurysm and Aneurysm, Brain, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of aneurysm wall inflammation as measured by HR-VW-MRI. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05959759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.