Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
NCT Number: NCT02002390
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.
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Notify Me18 year–80 year
All sexes
Interventional
Phase 2
Tianjin, Tianjin Municipality, 300052, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A sphingosine-1-phosphate receptor regulator
Other names: FTY720
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.
Time frame: up to 90 days
Outcomes are measured at baseline, 7 days, 14 days and 90 days after onset
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
Tianjin Medical University General Hospital
Other
Efficacy and Safety of FTY720 for the Treatment of Acute Stroke
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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