Efficacy and Safety of FTY720 for Acute Stroke

Tianjin Medical University

Status and phase: Completed; Phase 2

Conditions: Ischemic Cerebrovascular Accident; Stroke; Vascular Accident; Stroke, Acute; Cerebral Stroke

Treatments: Drug: Fingolimod

Study type: Interventional

Funder types: Other

Identifiers

NCT02002390

IRB2013-054-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups, including a placebo group

Fingolimod (FTY720) group

Experimental group

Description:

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

Treatment:

Drug: Fingolimod

Control group

Placebo Comparator group

Description:

Patients will receive usual care and drug use in hospital.

Treatment:

Drug: Fingolimod