NCT04890366

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 alteplase in patients with Acute Ischemic Stroke.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 6, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

May 11, 2021

Last Update Submit

June 2, 2022

Conditions

Acute Ischemic Stroke

Keywords

Dimethyl Fumarateimmune modulatorAlteplaseAcute Ischemic Strokeedema

Outcome Measures

Primary Outcomes (3)

  • changes in lesion volume

    measured by MRI

    baseline to day 7

  • changes in hemorrhage volume

    measured by MRI

    baseline to day 7

  • changes in 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.

    baseline to day 7

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Alteplase plus Dimethyl Fumarate

EXPERIMENTAL
Drug: Dimethyl Fumarate

Alteplase

NO INTERVENTION

Interventions

Dimethyl FumarateDRUG

Dimethyl fumarate 240mg orally twice daily for 3 consecutive days

Alteplase plus Dimethyl Fumarate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • more than 18years old
  • NIHSS score≥5
  • MRI shows anterior circulation infarction
  • Patients who meet Alteplase thrombolytic therapy within 4.5h
  • The time from onset to DMF application was less than 24 hours

You may not qualify if:

  • Hemorrhagic stroke
  • Patients who have received or plan to receive endovascular therapy
  • Other diseases of the central nervous system
  • Pre-existing neurological disability (mRS Score \>2)
  • Vertebrobasilar artery obstruction
  • Difficulty swallowing
  • Patients who cannot accept MRI examination
  • Abnormal liver function (transaminase higher than 2 times the normal upper limit)
  • The lymphocyte count was lower than the lower limit of normal value
  • Anti-tumor drugs, other immunosuppressive and immunomodulatory drugs are being used
  • Patients known to have hypersensitivity to dimethyl fumarate or any excipients
  • Pregnant and lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Ischemic StrokeEdema

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FumaratesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Junwei Hao, PhD,MD

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junwei Hao, PhD,MD

CONTACT

010-83199270haojunwei@vip.163.com

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

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 6, 2022

Record last verified: 2022-06

Locations

CN(1)