Efficacy and Safety of FTY720 for Acute Stroke

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University General Hospital
• Treatments: Fingolimod Hydrochloride

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