Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

NCT04890353 | Terminated Phase 1

• 1 other identifier: haojunwei4
• Study Type: interventional
• Target: 2
• 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 in alleviating neurologic deficits in patients with Acute Ischemic Stroke.

Conditions

Acute Ischemic Stroke

Keywords

Dimethyl Fumarate; acute ischemic stroke; immune modulation

Outcome Measures

Primary Outcomes (2)

• 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

• Lesion Volume

  Measured by MRI.

  day 7

Secondary Outcomes (12)

• The Modified Rankin Scale (mRS)

  day1

• The Modified Rankin Scale (mRS)

  day3

• The Modified Rankin Scale (mRS)

  day7

• The Modified Rankin Scale (mRS)

  day14

• The Modified Rankin Scale (mRS)

  day90

Study Arms (2)

standard management plus Dimethyl Fumarate

EXPERIMENTAL

Drug: Dimethyl fumarate

standard management

NO INTERVENTION

Interventions

Dimethyl fumarate DRUG

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

standard management plus Dimethyl Fumarate

Eligibility Criteria

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

You may qualify if:

• \>18 y of age;
• acute onset of focal neurological deficit consistent with acute ischemic stroke;
• measurable neurological deficit (NIHSS ≥ 5);
• anterior-circulation ischemic stroke defined by magnetic resonance angiography (MRA) and Diffusion-Weighted Imaging(DWI);
• onset of symptom to admission more than 4.5 h and less than 72 h. Patients who arrived within 0-4.5 h poststroke were treated with other medications according to the best accepted medical treatment guidelines.

You may not qualify if:

• Other diseases of the central nervous system
• There has been neurological disability in the past (mRS score\>2)
• Difficulty swallowing
• Arrhythmia, atrioventricular block
• Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs
• Macular edema
• MRA shows vertebral basilar artery obstruction
• Hemorrhagic stroke
• Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients of this product
• Pregnant and lactating women

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 18, 2021
• Study Start: December 1, 2021
• Primary Completion: February 8, 2023
• Study Completion: February 28, 2023
• Last Updated: October 25, 2023

Record last verified: 2021-05

Locations

CN (1)