Efficacy and Safety of FTY720 for Acute Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Vascular Accident Cerebral Stroke Ischemic Cerebrovascular Accident Stroke, Acute

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fingolimod (FTY720) group

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

Group Type EXPERIMENTAL

Fingolimod

Intervention Type DRUG

A sphingosine-1-phosphate receptor regulator

Control group

Patients will receive usual care and drug use in hospital.

Group Type PLACEBO_COMPARATOR

Fingolimod

Intervention Type DRUG

A sphingosine-1-phosphate receptor regulator

Interventions

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Fingolimod

A sphingosine-1-phosphate receptor regulator

Intervention Type DRUG

Other Intervention Names

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FTY720

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No