- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02002390
Efficacy and Safety of FTY720 for Acute Stroke
Efficacy and Safety of FTY720 for the Treatment of Acute Stroke
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Tianjin
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Tianjin, Tianjin, China, 300052
- Tianjin Medical University General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Fingolimod (FTY720) group
Drug: Fingolimod capsules will be administered as 0.5mg/day over a course of 3 consecutive days after stroke onset.
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A sphingosine-1-phosphate receptor regulator
Other Names:
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PLACEBO_COMPARATOR: Control group
Patients will receive usual care and drug use in hospital.
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A sphingosine-1-phosphate receptor regulator
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical improvement
Time Frame: up to 90 days
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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.
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up to 90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in image
Time Frame: up to 90 days
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Outcomes are measured at baseline, 7 days, 14 days and 90 days after onset
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up to 90 days
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Change in immunology function
Time Frame: up to 7 days
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Use the flow cytometry to measure the change at baseline, 1 day, 3 days, 7 days after drug use
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up to 7 days
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Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Stroke
- Ischemic Stroke
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunosuppressive Agents
- Immunologic Factors
- Sphingosine 1 Phosphate Receptor Modulators
- Fingolimod Hydrochloride
Other Study ID Numbers
- IRB2013-054-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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