Efficacy and Safety of FTY720 for Acute Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Fu-Dong Shi, 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.

Condition or disease Intervention/treatment Phase
Stroke Vascular Accident Cerebral Stroke Ischemic Cerebrovascular Accident Stroke, Acute Drug: Fingolimod 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 87 participants
Allocation: 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 : October 2012
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

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 Name: FTY720

Placebo Comparator: Control group
Patients will receive usual care and drug use in hospital.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Change in image [ Time Frame: up to 90 days ]
    Outcomes are measured at baseline, 7 days, 14 days and 90 days after onset

  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02002390

Contact: Fu-Dong Shi, MD,PhD

China, Tianjin
Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 300052
Contact: Fu-Dong Shi, MD,PhD   
Principal Investigator: Fu-Dong Shi, MD,PhD         
Sponsors and Collaborators
Tianjin Medical University General Hospital
Study Chair: Fu-Dong Shi, MD,PhD Tianjin Medical University General Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Fu-Dong Shi, Head of Neurology Department, Tianjin Medical University General Hospital Identifier: NCT02002390     History of Changes
Other Study ID Numbers: IRB2013-054-02
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Fu-Dong Shi, Tianjin Medical University General Hospital:
Stroke,Fingolimod(FTY 720), treatment

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs