Combination of the Immune Modulator Dimethyl Fumarate With Intraarterial Treatment in Acute Ischemic Stroke

NCT04891497 | Withdrawn Phase 2

• 1 other identifier: haojunwei5
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 combination with intraarterial treatment in patients with Acute Ischemic Stroke.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Immune Modulator; Dimethyl Fumarate; Intraarterial Treatment

Outcome Measures

Primary Outcomes (3)

• lesion volume

  measured by MRI

  day 1

• hemorrhage volume

  measured by MRI

  day 1

• 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 1

Secondary Outcomes (16)

• lesion volume

  day3

• lesion volume

  day7

• lesion volume

  day90

• hemorrhage volume

  day3

• hemorrhage volume

  day7

Study Arms (2)

Intraarterial Treatment plus Dimethyl Fumarate

EXPERIMENTAL

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Drug: Dimethyl Fumarate

Intraarterial Treatment plus placebo

PLACEBO COMPARATOR

Placebo 240mg orally twice daily for 3 consecutive days

Drug: Placebo

Interventions

Dimethyl Fumarate DRUG

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Intraarterial Treatment plus Dimethyl Fumarate

Placebo DRUG

Placebo 240mg orally twice daily for 3 consecutive days

Intraarterial Treatment plus placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old 2. NIHSS score\>6 3. For the first stroke, MRI showed anterior circulation infarction 4. Patients who meet the mechanical thrombectomy treatment by MRI assessment within 24 hours

You may not qualify if:

• Patients receiving Alteplase thrombolysis
• Other diseases of the central nervous system
• There has been a 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
• Magnetic resonance angiography shows vertebra-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

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 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 17, 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