Efficacy and Safety of FTY720 for Acute Stroke
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|ClinicalTrials.gov Identifier: NCT02002390|
Recruitment Status : Unknown
Verified September 2014 by Fu-Dong Shi, Tianjin Medical University General Hospital.
Recruitment status was: Recruiting
First Posted : December 5, 2013
Last Update Posted : September 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Stroke Vascular Accident Cerebral Stroke Ischemic Cerebrovascular Accident Stroke, Acute||Drug: Fingolimod||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||87 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of FTY720 for the Treatment of Acute Stroke|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||October 2014|
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.
- Clinical improvement [ Time Frame: up to 90 days ]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 ]Outcomes are measured at baseline, 7 days, 14 days and 90 days after onset
- Change in immunology function [ Time Frame: up to 7 days ]Use the flow cytometry to measure the change at baseline, 1 day, 3 days, 7 days after drug use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|