Efficacy and Safety of FTY720 for Acute Stroke

This study is currently recruiting participants.
Verified April 2014 by Tianjin Medical University General Hospital
Sponsor:
Information provided by (Responsible Party):
Fu-Dong Shi, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier:
NCT02002390
First received: November 24, 2013
Last updated: April 20, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Stroke
Vascular Accident
Cerebral Stroke
Ischemic Cerebrovascular Accident
Stroke, Acute
Drug: Fingolimod
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of FTY720 for the Treatment of Acute Stroke

Resource links provided by NLM:


Further study details as provided by Tianjin Medical University General Hospital:

Primary Outcome Measures:
  • Clinical improvement [ Time Frame: up to 90 days ] [ Designated as safety issue: Yes ]
    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:
  • Change in image [ Time Frame: up to 90 days ] [ Designated as safety issue: Yes ]
    Outcomes are measured at baseline, 7 days, 14 days and 90 days after onset

  • Change in immunology function [ Time Frame: up to 7 days ] [ Designated as safety issue: Yes ]
    Use the flow cytometry to measure the change at baseline, 1 day, 3 days, 7 days after drug use


Estimated Enrollment: 42
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

This study will enroll 42 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT02002390

Contacts
Contact: Fu-Dong Shi, MD,PhD fshi@tijmu.edu.cn

Locations
China, Tianjin
Tianjin Medical University General Hospital Recruiting
Tianjin, Tianjin, China, 300052
Contact: Fu-Dong Shi, MD,PhD       fshi@tijmu.edu.cn   
Principal Investigator: Fu-Dong Shi, MD,PhD         
Sponsors and Collaborators
Tianjin Medical University General Hospital
Investigators
Study Chair: Fu-Dong Shi, MD,PhD Tianjin Medical University General Hospital
  More Information

No publications provided

Responsible Party: Fu-Dong Shi, Head of Neurology Department, Tianjin Medical University General Hospital
ClinicalTrials.gov Identifier: NCT02002390     History of Changes
Other Study ID Numbers: IRB2013-054-02
Study First Received: November 24, 2013
Last Updated: April 20, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 23, 2014