Efficacy and Safety of FTY720 for Acute Stroke

NCT02002390 | Completed Phase 2 DMC

• 1 other identifier: IRB2013-054-02
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Stroke,Fingolimod(FTY 720), treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 90 days

Secondary Outcomes (2)

• Change in image

  up to 90 days

• Change in immunology function

  up to 7 days

Study Arms (2)

Fingolimod (FTY720) group

EXPERIMENTAL

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

Drug: Fingolimod

Control group

PLACEBO COMPARATOR

Patients will receive usual care and drug use in hospital.

Drug: Fingolimod

Interventions

Fingolimod DRUG

A sphingosine-1-phosphate receptor regulator

Also known as: FTY720

Control group; Fingolimod (FTY720) group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tianjin Medical University General Hospital: lead

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Related Publications (3)

• 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.

  PMID: 35720286 DERIVED

• 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.

  PMID: 26202811 DERIVED

• 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.

  PMID: 25003359 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Fu-Dong Shi, MD,PhD

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology Department

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: December 5, 2013
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 17, 2018

Record last verified: 2018-10

Locations

CN (1)