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Completed

NCT Number: NCT05959759

Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Neurosurgical Institute & Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

dimethyl fumarate

Drug

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.

Placebo

Drug

placebo with the same appearance (color, taste, size, shape), 30 patients for this arm.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change of aneurysmal morphology parameter

    Time frame: 6 months

    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.

  2. Change of inflammatory markers in patients

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Chao Yang Hospital
  • Beijing Neurosurgical Institute
  • Henan Provincial People's Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 25, 2023
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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