Efficacy and Safety of FTY720 for Acute Stroke

Phase 2

Completed

• Conditions: Vascular Accident; Stroke; Cerebral Stroke; Stroke, Acute; Ischemic Cerebrovascular Accident
• Interventions: Drug: Fingolimod

• Registration Number: NCT02002390
• Lead Sponsor: Tianjin Medical University General Hospital

Brief 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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-11-24
• Study First Submitted QC: 2013-11-30
• Study First Posted: 2013-12-05
• Primary Completion: 2014-10-01
• Study Completion: 2014-10-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-15
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Age 18-80 years
• Clinical presentation of spontaneous intracerebral hemorrhage/ischemic stroke
• MRI/MRA scan compatible with spontaneous intracerebral hemorrhage/ ischemic stroke
• Time to fty720 treatment< 72 h from symptom onset
• Glasgow Coma Score >6 on initial presentation or improvement to a Glasgow Coma Score >6 within the time frame for enrollment.
• Primary supratentorial ICH of ≥5cc and <30cc
• TOAST: Large-artery atherosclerosis

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Exclusion Criteria

• Patients who will undergo surgical evacuation of intracerebral hemorrhage
• Inability to undergo neuroimaging with Magnetic Resonance
• Glasgow Coma Score < 6.
• Baseline modified Rankin Scale score >1
• Primary intraventricular hemorrhage ICH due to coagulopathy (PT > 15 s or International Normalized Ratio > 1.3, Partial Thromboplastin Time > 36) or trauma
• Thrombocytopenia: platelet count <100 000
• Clinically significant hepatic disease as demonstrated by history, clinical exam (ascites, varices), or laboratory findings (LFTs >2x normal, coagulopathy as described)
• Comorbid conditions likely to complicate therapy including but not limited to the following: a history of New York Heart Association class II, III, or IV Congestive Heart Failure; end-stage acquired immune deficiency syndrome
• Pregnancy
• Malignancy (history of or active)
• Bradyarrhythmia and Atrioventricular Block
• Concomitant use with antineoplastic,immunosuppressive or immune modulating therapies
• Macular Edema

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Fingolimod	Patients will receive usual care and drug use in hospital.
Fingolimod (FTY720) group	Fingolimod	Drug: Fingolimod capsules will be administered as 0.5mg/day over a course of 3 consecutive days after stroke onset.

Primary Outcome Measures

Name	Time	Method
Clinical improvement	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.

Secondary Outcome Measures

Name	Time	Method
Change in immunology function	up to 7 days	Use the flow cytometry to measure the change at baseline, 1 day, 3 days, 7 days after drug use
Change in image	up to 90 days	Outcomes are measured at baseline, 7 days, 14 days and 90 days after onset

Trial Locations

Locations (1)

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China