Efficacy and Safety of FTY720 for Acute Stroke
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.
Ischemic Cerebrovascular Accident
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of FTY720 for the Treatment of Acute Stroke|
- Clinical improvement [ Time Frame: up to 90 days ] [ Designated as safety issue: Yes ]Neurofunctional assessment including NIHSS, modified Barthel Index, modified Rankin Scale,and Glasgow coma scale are used to describe the clinical improvement at baseline, 7days, 14days, 30days and 90days.
- Change in image [ Time Frame: up to 90 days ] [ Designated as safety issue: Yes ]Outcomes are measured at baseline, 7 days, 14 days and 90 days after onset
- Change in immunology function [ Time Frame: up to 7 days ] [ Designated as safety issue: Yes ]Use the flow cytometry to measure the change at baseline, 1 day, 3 days, 7 days after drug use
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2014|
|Estimated Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Experimental: Fingolimod (FTY720) group
Drug: Fingolimod capsules will be administered as 0.5mg/day over a course of 3 consecutive days after stroke onset.
A sphingosine-1-phosphate receptor regulator
Other Name: FTY720
Placebo Comparator: Control group
Patients will receive usual care and drug use in hospital.
This study will enroll 42 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02002390
|Contact: Fu-Dong Shi, MD,PhDfirstname.lastname@example.org|
|Tianjin Medical University General Hospital||Recruiting|
|Tianjin, Tianjin, China, 300052|
|Contact: Fu-Dong Shi, MD,PhD email@example.com|
|Principal Investigator: Fu-Dong Shi, MD,PhD|
|Study Chair:||Fu-Dong Shi, MD,PhD||Tianjin Medical University General Hospital|