Dimethyl Fumarate for the Treatment of Intracerebral Hemorrhage

NCT04890379 | Withdrawn Phase 2

• 1 other identifier: haojunwei2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracerebral Hemorrhage

Keywords

Dimethyl Fumarate; Intracerebral Hemorrhage(ICH); perihematomal edema(PHE); neurologic deficit; immune modulator

Outcome Measures

Primary Outcomes (3)

• Volume of Perihematomal edema(PHE)

  measured by MRI

  day7

• Glasgow Coma Scale (GCS)

  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)

  The NIHSS score ranges from 0 to 42 points. The higher the score, the more severe the neurological impairment.

  day 7

Secondary Outcomes (21)

• Volume of Perihematomal edema(PHE)

  day1

• Volume of Perihematomal edema(PHE)

  day3

• Volume of Perihematomal edema(PHE)

  day14

• Volume of Perihematomal edema(PHE)

  day90

• Glasgow Coma Scale (GCS)

  day 1

Study Arms (2)

standard management plus Dimethyl Fumarate

EXPERIMENTAL

Drug: Dimethyl fumarate

standard management plus placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Dimethyl fumarate DRUG

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

standard management plus Dimethyl Fumarate

Placebo DRUG

Placebo 240mg orally twice daily for 3 consecutive days

standard management plus placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Neurologic Manifestations

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 18, 2021
• Study Start: June 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 25, 2023

Record last verified: 2021-05

Locations

CN (1)