Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.

NCT05959759 | Unknown Phase 4 FDA Drug

• 1 other identifier: BTHDMF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Aneurysm; Aneurysm, Brain; Inflammation Vascular

Keywords

Dimethyl Fumarate; High resolution magnetic resonance

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• Change of aneurysmal morphology parameter

  6 months

• Change of inflammatory markers in patients

  6 months

Study Arms (2)

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)

Drug: Dimethyl fumarate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.

Dimethyl fumarate

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Beijing Neurosurgical Institute: collaborator
• Beijing Chao Yang Hospital: collaborator
• Henan Provincial People's Hospital: collaborator

Study Sites (1)

Beijing Neurosurgical Institute & Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (1)

• 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.

  PMID: 38772883 DERIVED

MeSH Terms

Conditions

Intracranial Aneurysm

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Yisen Zhang, MD

  Beijing Neurosurgical Institute & Beijing Tiantan Hospital

  STUDY DIRECTOR

Central Study Contacts

Yisen Zhang, MD

CONTACT

+86-15001232615; zhang-yisen@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: July 25, 2023
• Study Start: July 31, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 1, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication
• Access Criteria: Data are available on reasonable request.

Locations

CN (1)