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Efficacy and Safety of FTY720 for Acute Stroke

Sponsor
Tianjin Medical University General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02002390
Collaborator
(none)
22
Enrollment
1
Location
2
Arms
24
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
22 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of FTY720 for the Treatment of Acute Stroke
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Oct 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Fingolimod (FTY720) group

Drug: Fingolimod capsules will be administered as 0.5mg/day over a course of 3 consecutive days after stroke onset.

Drug: Fingolimod
A sphingosine-1-phosphate receptor regulator
Other Names:
  • FTY720

    		•
    Placebo Comparator: Control group

    Patients will receive usual care and drug use in hospital.

    Drug: Fingolimod
    A sphingosine-1-phosphate receptor regulator
    Other Names:
  • FTY720

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Change in image [up to 90 days]

      Outcomes are measured at baseline, 7 days, 14 days and 90 days after onset

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin Medical University General Hospital Tianjin Tianjin China 300052

    Sponsors and Collaborators

    • Tianjin Medical University General Hospital

    Investigators

    • Principal Investigator: Fu-Dong Shi, MD,PhD, Tianjin Medical University General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fu-Dong Shi, Head of Neurology Department, Tianjin Medical University General Hospital
    ClinicalTrials.gov Identifier:
    NCT02002390
    Other Study ID Numbers:
    • IRB2013-054-02
    First Posted:
    Dec 5, 2013
    Last Update Posted:
    Oct 17, 2018
    Last Verified:
    Oct 1, 2018
    Keywords provided by Fu-Dong Shi, Head of Neurology Department, Tianjin Medical University General Hospital
    Stroke,Fingolimod(FTY 720), treatment
    Additional relevant MeSH terms:
    Stroke
    Ischemic Stroke
    Fingolimod Hydrochloride

    Study Results

    No Results Posted as of Oct 17, 2018