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Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.

Primary Purpose

Intracranial Aneurysm, Aneurysm, Brain, Inflammation Vascular

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dimethyl fumarate
Placebo
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracranial Aneurysm focused on measuring Dimethyl Fumarate, High resolution magnetic resonance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 12 months. Current treatment with drugs that might have an anti-inflammatory effect (aspirin, statins, immunosuppressive drugs, 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.

Sites / Locations

  • Beijing Neurosurgical Institute & Beijing Tiantan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dimethyl fumarate

Placebo

Arm Description

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)

placebo with the same appearance (color, taste, size, shape)

Outcomes

Primary Outcome Measures

Change of aneurysm wall inflammation as measured by HR-VW-MRI.
Change of aneurysm wall enhancement index of at least 20% on HR-VM-MRI at the end of 6 months of dimethyl fumarate treatment, compared to no treatment.

Secondary Outcome Measures

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.
Change of inflammatory markers in patients
Changes in CRP, TNF-α, IL-1β and IL-6 in patients with unruptured IAs from before treatment to the 6 months follow-up. The CRP, TNF-α, IL-1β and IL-6 levels will be measured at before treatment and at 6 months follow-up.

Full Information

First Posted
July 16, 2023
Last Updated
July 16, 2023
Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Neurosurgical Institute, Beijing Chao Yang Hospital, Henan Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05959759
Brief Title
Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.
Official Title
Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms: a Double Blind Randomized Controlled Trail
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 31, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tiantan Hospital
Collaborators
Beijing Neurosurgical Institute, Beijing Chao Yang Hospital, Henan Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracranial Aneurysm, Aneurysm, Brain, Inflammation Vascular
Keywords
Dimethyl Fumarate, High resolution magnetic resonance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dimethyl fumarate
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo with the same appearance (color, taste, size, shape)
Intervention Type
Drug
Intervention Name(s)
Dimethyl fumarate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo with the same appearance (color, taste, size, shape), 30 patients for this arm.
Primary Outcome Measure Information:
Title
Change of aneurysm wall inflammation as measured by HR-VW-MRI.
Description
Change of aneurysm wall enhancement index of at least 20% on HR-VM-MRI at the end of 6 months of dimethyl fumarate treatment, compared to no treatment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change of aneurysmal morphology parameter
Description
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.
Time Frame
6 months
Title
Change of inflammatory markers in patients
Description
Changes in CRP, TNF-α, IL-1β and IL-6 in patients with unruptured IAs from before treatment to the 6 months follow-up. The CRP, TNF-α, IL-1β and IL-6 levels will be measured at before treatment and at 6 months follow-up.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 12 months. Current treatment with drugs that might have an anti-inflammatory effect (aspirin, statins, immunosuppressive drugs, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yisen Zhang, MD
Phone
+86-15001232615
Email
zhang-yisen@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yisen Zhang, MD
Organizational Affiliation
Beijing Neurosurgical Institute & Beijing Tiantan Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Neurosurgical Institute & Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yisen Zhang, MD
Phone
+86-15001232615
Email
zhang-yisen@163.com
First Name & Middle Initial & Last Name & Degree
Jiliang Huang
Phone
+86-18829793414
Email
linkgo@qq.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available on reasonable request.
IPD Sharing Time Frame
starting 6 months after publication
IPD Sharing Access Criteria
Data are available on reasonable request.

Learn more about this trial

Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.

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