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Efficacy and Safety of FTY720 for Acute Stroke

Primary Purpose

Stroke, Vascular Accident, Cerebral Stroke

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Fingolimod

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke,Fingolimod(FTY 720), treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fingolimod (FTY720) group

Control group

Arm Description

Drug: Fingolimod capsules will be administered as 0.5mg/day over a course of 3 consecutive days after stroke onset.

Patients will receive usual care and drug use in hospital.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in image

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

Change in immunology function

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

Full Information

NCT ID

NCT02002390

First Posted

November 24, 2013

Last Updated

October 15, 2018

Sponsor

Tianjin Medical University General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02002390

Brief Title

Efficacy and Safety of FTY720 for Acute Stroke

Official Title

Efficacy and Safety of FTY720 for the Treatment of Acute Stroke

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

October 1, 2014 (Actual)

Study Completion Date

October 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tianjin Medical University General Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Vascular Accident, Cerebral Stroke, Ischemic Cerebrovascular Accident, Stroke, Acute

Keywords

Stroke,Fingolimod(FTY 720), treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fingolimod (FTY720) group

Arm Type

Experimental

Arm Description

Drug: Fingolimod capsules will be administered as 0.5mg/day over a course of 3 consecutive days after stroke onset.

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Patients will receive usual care and drug use in hospital.

Intervention Type

Drug

Intervention Name(s)

Fingolimod

Other Intervention Name(s)

FTY720

Intervention Description

A sphingosine-1-phosphate receptor regulator

Primary Outcome Measure Information:

Title

Clinical improvement

Description

Time Frame

up to 90 days

Secondary Outcome Measure Information:

Title

Change in image

Description

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

Time Frame

up to 90 days

Title

Change in immunology function

Description

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

Time Frame

up to 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fu-Dong Shi, MD,PhD

Organizational Affiliation

Tianjin Medical University General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tianjin Medical University General Hospital

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300052

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

35720286

Citation

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.

Results Reference

derived

PubMed Identifier

26202811

Citation

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.

Results Reference

derived

PubMed Identifier

25003359

Citation

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.

Results Reference

derived

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Efficacy and Safety of FTY720 for Acute Stroke

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