NCT02002390

Efficacy and Safety of FTY720 for Acute Stroke

Efficacy and Safety of FTY720 for the Treatment of Acute Stroke

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Tianjin Medical University General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

• Stroke
• Vascular Accident
• Cerebral Stroke
• Ischemic Cerebrovascular Accident
• Stroke, Acute

Interventions

Type	Name	Description
DRUG	Fingolimod	A sphingosine-1-phosphate receptor regulator

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-12-05
• Last updated: 2018-10-17

Locations

1 site across 1 country: China