Efficacy and Safety of FTY720 for Acute Stroke

This study is currently recruiting participants.
Verified January 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: January 16, 2014
Last verified: January 2014

November 24, 2013
January 16, 2014
October 2012
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02002390 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of FTY720 for Acute Stroke
Efficacy and Safety of FTY720 for the Treatment of Acute Stroke

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stroke
  • Vascular Accident
  • Cerebral Stroke
  • Ischemic Cerebrovascular Accident
  • Stroke, Acute
Drug: Fingolimod
A sphingosine-1-phosphate receptor regulator
Other Name: FTY720
  • Experimental: Fingolimod (FTY720) group
    Drug: Fingolimod capsules will be administered as 0.5mg/day over a course of 3 consecutive days after stroke onset.
    Intervention: Drug: Fingolimod
  • Placebo Comparator: Control group
    Patients will receive usual care and drug use in hospital.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Fu-Dong Shi, MD,PhD fshi@tijmu.edu.cn
China
 
NCT02002390
IRB2013-054-02
Yes
Fu-Dong Shi, Tianjin Medical University General Hospital
Tianjin Medical University General Hospital
Not Provided
Study Chair: Fu-Dong Shi, MD,PhD Tianjin Medical University General Hospital
Tianjin Medical University General Hospital
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP