Efficacy and Safety of FTY720 for Acute Stroke

Recruiting

Phase 2 Results N/A

Trial Description

Stroke is one of the main severe disease of public health importance. Increasing evidence suggests that inflammatory mechanisms plays a significant role in stroke. So, immune targets are supposed to be an effective one. The sphingosine-1-phosphate receptor regulator Fingolimod(FTY720)is an effective immunology modulator which has been widely used in autoimmune disease and has been testified effective on stoke animal models.

Detailed Description

This study will enroll 87 stroke patients who have been diagnosed with stroke and meet the inclusion criteria.
After successfully meeting initial screening criteria, investigators will contact the family, explain the study, and send a consent form for their review.
After that, patients will be given 0.5mg/day oral fingolimod over a course of 3 consecutive days , then investigators will make a neurofunctional assessment before and 7days, 30 days and 90days after oral fingolimod. And Magnetic Resonance of the brain before, 7days, 14days and 90days after oral fingolimod. Furthermore 5ml intravenous blood for flow cytometry is also taken before and 1day,3days,7days after fingolimod use.

Conditions

Interventions

  • Fingolimod Drug
    Other Names: Fingolimod Hydrochloride
    Intervention Desc: A sphingosine-1-phosphate receptor regulator
    ARM 1: Kind: Experimental
    Label: Fingolimod (FTY720) group
    Description: Drug: Fingolimod capsules will be administered as 0.5mg/day over a course of 3 consecutive days after stroke onset.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Clinical improvement up to 90 days Yes
Secondary Change in image up to 90 days Yes
Secondary Change in immunology function up to 7 days Yes

Sponsors