Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

October 24, 2023 updated by: Xuanwu Hospital, Beijing
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Xuanwu Hospital, Beijing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: standard management plus Dimethyl Fumarate
Drug: Dimethyl fumarate
Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
Placebo Comparator: standard management plus placebo
Drug: Placebo
Placebo 240mg orally twice daily for 3 consecutive days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Volume of Perihematomal edema(PHE)
Time Frame: day7
measured by MRI
day7
Glasgow Coma Scale (GCS)
Time Frame: day7
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
day7
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: day 7
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
day 7

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Volume of Perihematomal edema(PHE)
Time Frame: day1
measured by MRI
day1
Volume of Perihematomal edema(PHE)
Time Frame: day3
measured by MRI
day3
Volume of Perihematomal edema(PHE)
Time Frame: day14
measured by MRI
day14
Volume of Perihematomal edema(PHE)
Time Frame: day90
measured by MRI
day90
Glasgow Coma Scale (GCS)
Time Frame: day 1
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
day 1
Glasgow Coma Scale (GCS)
Time Frame: day 3
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
day 3
Glasgow Coma Scale (GCS)
Time Frame: day 14
The GCS score ranges from 3 to 15 points. The lower the score, the more severe the patient's coma is.
day 14
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: day1
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
day1
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: day3
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
day3
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: day14
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
day14
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: day90
The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.
day90
The Modified Rankin Scale (mRS)
Time Frame: day1
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
day1
The Modified Rankin Scale (mRS)
Time Frame: day3
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
day3
The Modified Rankin Scale (mRS)
Time Frame: day7
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
day7
The Modified Rankin Scale (mRS)
Time Frame: day14
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
day14
The Modified Rankin Scale (mRS)
Time Frame: day90
The mRS score ranges from 0 to 7 points. The higher the score, the more severe the neurological recovery state of stroke patients.
day90
The Modified Barthel Index (mBI)
Time Frame: day 1
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
day 1
The Modified Barthel Index (mBI)
Time Frame: day 3
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
day 3
The Modified Barthel Index (mBI)
Time Frame: day 7
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
day 7
The Modified Barthel Index (mBI)
Time Frame: day 14
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
day 14
The Modified Barthel Index (mBI)
Time Frame: day 90
The mBI score ranges from 0 to 100 points. The higher the score, the higher the degree of independence of stroke patients.
day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • haojunwei2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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