AzTrials
AzTrials

StrokePhase 2NCT02002390

Efficacy and Safety of FTY720 for Acute Stroke

A Phase 2 study testing Fingolimod in people with Stroke and Vascular Accident, run by Tianjin Medical University General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Vascular Accident, Cerebral Stroke
What is being tested?
Fingolimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
1 siteChina
Study dates
Oct 2012to 1 Oct 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Fingolimod
Keywords
Stroke,Fingolimod(FTY 720), treatment
Medical subject headings
Stroke, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FingolimodDrug

    Also called FTY720

    A sphingosine-1-phosphate receptor regulator

Study groups in NCT02002390
Study groupRoleWhat they receive
Fingolimod (FTY720) groupExperimentalDrug: Fingolimod capsules will be administered as 0.5mg/day over a course of 3 consecutive days after stroke onset.
Receives: Drug: Fingolimod
Control groupPlacebo comparatorPatients will receive usual care and drug use in hospital.
Receives: Drug: Fingolimod

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical improvement

    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.

    Measured: up to 90 days

Secondary outcomes (2)

  1. Change in image

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

    Measured: up to 90 days

  2. Change in immunology function

    Use the flow cytometry to measure the change at baseline, 1 day, 3 days, 7 days after drug use

    Measured: up to 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2013 (estimated)
  2. Study startOct 2012
  3. Primary completion1 Oct 2014
  4. Study completion1 Oct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02002390
Sponsor's protocol ID
IRB2013-054-02
Status last verified
Oct 2018
First submitted
24 Nov 2013
Last updated
17 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Li HD, Li R, Kong Y, Zhang W, Qi C, Wang D, Hao H, Liu Q. Selective Sphingosine 1-Phosphate Receptor 1 Modulation Augments Thrombolysis of Low-Dose Tissue Plasminogen Activator Following Cerebrovascular Thrombosis. Front Immunol. 2022 May 27;13:801727. doi: 10.3389/fimmu.2022.801727. eCollection 2022.

    PubMed 35720286

  • Zhu Z, Fu Y, Tian D, Sun N, Han W, Chang G, Dong Y, Xu X, Liu Q, Huang D, Shi FD. Combination of the Immune Modulator Fingolimod With Alteplase in Acute Ischemic Stroke: A Pilot Trial. Circulation. 2015 Sep 22;132(12):1104-1112. doi: 10.1161/CIRCULATIONAHA.115.016371. Epub 2015 Jul 22.

    PubMed 26202811

  • Fu Y, Hao J, Zhang N, Ren L, Sun N, Li YJ, Yan Y, Huang D, Yu C, Shi FD. Fingolimod for the treatment of intracerebral hemorrhage: a 2-arm proof-of-concept study. JAMA Neurol. 2014 Sep;71(9):1092-101. doi: 10.1001/jamaneurol.2014.1065.

    PubMed 25003359

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fingolimod in people with Stroke and Vascular Accident, run by Tianjin Medical University General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical improvement (time frame: up to 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02002390, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in