Skip to main content
OpenTrials
Completed

NCT Number: NCT02002390

Efficacy and Safety of FTY720 for 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fingolimod

Drug

A sphingosine-1-phosphate receptor regulator

Other names: FTY720

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Official study title

Efficacy and Safety of FTY720 for the Treatment of Acute Stroke

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2013
Registry last updated
Oct 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.