Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

NCT ID: NCT04890379

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The investigators conduct this study to investigate whether oral administration of Dimethyl Fumarate, a Food and Drug Administration-approved drug for multiple sclerosis, is safe and effective in alleviating PHE and neurologic deficits in patients with ICH.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracerebral Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

standard management plus Dimethyl Fumarate

Group Type EXPERIMENTAL

Dimethyl fumarate

Intervention Type DRUG

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

standard management plus placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 240mg orally twice daily for 3 consecutive days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dimethyl fumarate

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Intervention Type DRUG

Placebo

Placebo 240mg orally twice daily for 3 consecutive days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Men and nonpregnant women aged 18 years and older
2. a primary supratentorial ICH of 5 to 30 mL
3. symptom onset less than 72 hours prior to admission
4. a Glasgow Coma Scale (GCS) score of 6 or greater
5. basal ganglia hemorrhage only

Exclusion Criteria

1. patients with a GCS score of 3 to 5
2. planned surgical evacuation of a large hematoma (\>30 mL)
3. various degrees of dysphagia,and nausea/vomiting, any of which renders oral administration of fingolimod difficult
4. patients with hematoma expansion
5. secondary ICH
6. preexisting disability (modified Rankin Scale \[mRS\] score \>1)
7. any history of bradycardia or atrioventricular block
8. concomitant use of antineoplastic, immunosuppressive, or immune-modulating therapies
9. macular edema
10. Patients with known hypersensitivity to dimethyl fumarate or to any excipient of this product
11. Pregnant and lactating women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

haojunwei2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Clinical Plan of Ischemic Stroke
NCT04953663 UNKNOWN PHASE1/PHASE2