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Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms.

NCT05959759 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-07-25

No results posted yet for this study

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

Interventions

DRUG

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), 30 patients for this arm.

DRUG

Placebo

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

Sponsors & Collaborators

  • Beijing Neurosurgical Institute

    collaborator OTHER

  • Beijing Chao Yang Hospital

    collaborator OTHER

  • Henan Provincial People's Hospital

    collaborator OTHER

  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Yisen Zhang, MD · Beijing Neurosurgical Institute & Beijing Tiantan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2023-12-31
Completion
2024-06-01
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05959759 on ClinicalTrials.gov