Study Results
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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RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2024-03-18
2027-12-31
Brief Summary
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Detailed Description
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The effects of TS23 will be evaluated on two following primary outcomes using a utility function: 1) primary safety outcome: any intracerebral hemorrhage at 30 (+/-4) hours and 2) primary efficacy outcome: NIH Stroke Scale score at 30 (+/-4) hours after drug administration. The study will follow participants for 90 (+/-7) days.
Primary Objective: To identify a dose of TS23 that is safe and more efficacious than placebo for the treatment of patients from 4.5 to 24 hours of last known well, who have evidence of core-penumbra mismatch on perfusion imaging and are not a candidate for standard of care reperfusion therapies.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
TS23
Monoclonal antibody
Dose 1 TS23
low dose
TS23
Monoclonal antibody
Dose 2 TS23
next higher dose
TS23
Monoclonal antibody
Dose 3 TS23
next higher dose
TS23
Monoclonal antibody
Dose 4 TS23
highest dose
TS23
Monoclonal antibody
Interventions
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TS23
Monoclonal antibody
Eligibility Criteria
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Inclusion Criteria
2. Suspected anterior circulation acute ischemic stroke
3. NIH Stroke Scale score ≥4 prior to randomization
a. The participant must have a clearly disabling deficit if NIHSS is 4-5.
4. Favorable baseline neuroimaging consisting of all of the following:
1. ASPECTS of 6 or more on CT (or ASPECTS of ≥7 on MRI)
2. Favorable perfusion imaging on CT perfusion (CTP)/MR-perfusion weighted imaging (PWI) consisting of all of the following:
i. Mismatch ratio of penumbra: core \>1.2 ii. Mismatch volume \>10 cc iii. Core \<70 cc
c. If CT hypodensity is present, then in the investigator's visual assessment, the total acute infarct volume combined area of (a) the CT hypodensity and (b) the perfusion-based core volume (CBF\<30%) should be smaller than perfusion-based volume (area of Tmax\>6s minus CBF\<30%).
5. Able to receive assigned study drug within 4.5 to 24 hours of stroke onset or last known well.
6. Able to receive assigned study drug within 120 minutes of qualifying perfusion imaging. \*
7. Informed consent for the study participation obtained from participant or their legally authorized representatives.
Exclusion Criteria
1. Patients who undergo groin puncture but clot engagement is not attempted due to spontaneous distal migration are permitted to be enrolled in the trial if all other eligibility criteria are met.
2. Patients who undergo groin puncture but clot is not engaged due to reasons other than spontaneous distal migration are NOT permitted.
2. Received or planned to receive intravenous thrombolysis.
3. Pre-stroke modified Rankin score \>2.
4. Previous treatment with TS23 or known previous allergy to antibody therapy.
5. Known pregnancy, women who are breastfeeding or plan to breastfeed within 3 months of receiving TS23 or have a positive urine or serum pregnancy test for women of childbearing potential.
6. Known previous stroke in the past 90 days.
7. Known previous intracranial hemorrhage, intracranial neoplasm, subarachnoid hemorrhage, or arterial venous malformation.
8. Known active diagnosis of intracranial neoplasm.
9. Clinical presentation suggestive of a subarachnoid hemorrhage, even if initial CT scan was normal.
10. Surgery or biopsy of parenchymal organ in the past 30 days.
11. Known trauma with internal injuries or persistent ulcerative wounds in the past 30 days.
12. Severe head trauma in the past 90 days.
13. Persistent systolic blood pressure \>180mmHg or diastolic blood pressure \>105mmHg despite best medical management.
14. Serious systemic hemorrhage in the past 30 days.
15. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with International Normalized Ratio (INR) \>1.7.
16. Platelets \<100,000/mm3.
17. Hematocrit \<25 %.
18. Elevated aPTT above laboratory upper limit of normal.
19. Creatinine \> 4 mg/dl, or patients receiving renal dialysis, regardless of creatinine.
20. Received the following within the previous 24 hours:
1. If patient received unfractionated heparin within the last 24 hours, the patient must have an aPTT within normal range prior to enrollment.
2. Low molecular weight heparins such as Dalteparin, enoxaparin, tinzaparin in full dose within the previous 24 hours.
21. Received Factor Xa inhibitors (such as Fondaparinux, apixaban or rivaroxaban) within the past 48 hours.
22. Received direct thrombin inhibitors (e.g., argatroban, dabigatran, bivalirudin, desirudin, lepirudin) within 48 hours.
23. Received glycoprotein IIb/IIIa inhibitors within the past 14 days.
24. Known pre-existing neurological or psychiatric disease which would confound the neurological/functional evaluations.
25. Current participation in another research drug treatment protocol (i.e., participants could not start another experimental agent until after 90 days).
26. Concurrent acute myocardial infarction, pulmonary embolism, deep venous thrombosis or other thrombotic event that requires anticoagulation or anti-platelet treatment.
18 Years
ALL
No
Sponsors
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University of Cincinnati
OTHER
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Medical University of South Carolina
OTHER
University of Arizona
OTHER
Translational Sciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eva Mistry, MBBS
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Alabama Hospital
Birmingham, Alabama, United States
Banner University Medical Center
Phoenix, Arizona, United States
Mayo Clinic Phoenix
Phoenix, Arizona, United States
Banner University Medical Center - Tucson
Tucson, Arizona, United States
UCSD Health La Jolla
La Jolla, California, United States
Kaiser Permanente Los Angeles
Los Angeles, California, United States
Sutter Medical Center
Sacramento, California, United States
UCSD Medical Center- Hillcrest Hospital
San Diego, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Christiana Hospital
Newark, Delaware, United States
UF Health Shands Hospital
Gainesville, Florida, United States
Jackson Memorial Hospital
Miami, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Baptist Healthcare System, Inc.
Lexington, Kentucky, United States
University of Louisville Hospital
Louisville, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
M Health Fairview Ridges Hospital
Burnsville, Minnesota, United States
M Health Fairview Southdale Hospital
Edina, Minnesota, United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
JFK Medical Center
Edison, New Jersey, United States
NYU Langone Health
Brooklyn, New York, United States
Buffalo General Medical Center
Buffalo, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Mount Sinai West
New York, New York, United States
The Mount Sinai Hospital
New York, New York, United States
NYP Columbia University Medical Center
New York, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
Westchester Medical Center
Valhalla, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Ascension St. John
Tulsa, Oklahoma, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Saint Luke's Hospital of Bethlehem Pennsylvania
Bethlehem, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Medical University of South Carolina University Hospital
Charleston, South Carolina, United States
Prisma Health Greenville Memorial
Greenville, South Carolina, United States
Methodist University Hospital
Memphis, Tennessee, United States
Memorial Hermann Texas Medical Center
Houston, Texas, United States
University of Utah Healthcare
Salt Lake City, Utah, United States
UVA Medical Center
Charlottesville, Virginia, United States
VCU Medical Center
Richmond, Virginia, United States
Harborview Medical Center
Seattle, Washington, United States
Ascension Columbia St. Mary's Hospital
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Felix Guerra Castanon, MD
Role: primary
Savdeep Singh, MD
Role: primary
Firas Kaddouh, MD, MHS
Role: primary
Maryo Jajo
Role: primary
Royya Modir, MD
Role: backup
Navdeep Sangha, MD
Role: primary
Maryo Jajo
Role: primary
Royya' Modir, MD
Role: backup
Ajay Tunguturi, MD
Role: primary
James Giles, MD, PhD
Role: primary
Jason Nomura, MD
Role: primary
Amita Singh, MD, MS
Role: primary
Andrea Escobar
Role: primary
Gillian Gordon Perue, MD, MBBS, DM
Role: backup
Nicolas Bianchi, MD
Role: primary
James Siegler, MD, FAHA
Role: primary
Heena Olalde
Role: primary
Enrique Leira, MD
Role: backup
Murali Kolikonda, MD
Role: primary
Franklin Echevarria
Role: backup
Isaac Abecassis, MD
Role: primary
Rahul Mahajan, MD, PhD
Role: primary
Aneesh Singhal, MD, MBBS
Role: primary
Jessica Staloch
Role: primary
Muhammad Affan, MD, MBBS
Role: backup
Jessica Staloch
Role: primary
Muhammad Affan, MD,MBBS
Role: backup
Jessica Staloch
Role: primary
Muhammad Affan, MD,MBBS
Role: backup
Ganesh Asaithambi, MD
Role: primary
Charles Kircher, MD
Role: primary
Nancy Gadallah, DO
Role: primary
Maria Cotrina-Vidal
Role: primary
Aaron Lord, MD, MSc
Role: backup
Rohan Arora
Role: primary
Laura Stein, MD, MPH
Role: primary
Laura Stein, MD, MPH
Role: primary
Angela Velazquez
Role: primary
Shivani Ghoshal, MD
Role: backup
Deb Lena
Role: primary
Julius-Gene LaTorre, MD, MPH
Role: backup
Gurmeen Kaur, MD
Role: primary
Rosanna Escobar-Spadina
Role: primary
Alexander Limkakeng, MD, MHSc
Role: backup
Yasmin Aziz, MD
Role: primary
Jan Bittar, MD
Role: primary
Rahul Rahangdale, MD
Role: primary
Kishan Patel, MD
Role: primary
Daniel Ackerman, MD
Role: primary
Nina Gentile, MD
Role: primary
Farhan Khan, MD
Role: primary
Caitlan LeMatty
Role: primary
Christine Holmstedt, DO
Role: backup
Sanjeev Sivakumar, MD
Role: primary
Quentin Thacker
Role: primary
Balaji Krishnaiah, MD
Role: backup
Prasen Marella
Role: primary
Andrew Barreto, MD, MS
Role: backup
Vivek Reddy, MD, MMM
Role: primary
Amna Sohail, MBBS, MD
Role: primary
Shraddha Mainali, MD
Role: primary
David Tirschwell, MD, MSc.
Role: primary
Lakiesha Coleman
Role: primary
William Taylor, DO
Role: backup
Other Identifiers
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TS23-U202
Identifier Type: -
Identifier Source: org_study_id