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RECRUITING
NCT07392450
PHASE2

A Study of TAK-755 in Adults With Acute Ischemic Stroke

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

Acute ischemic stroke (AIS) is a medical emergency that happens because of a sudden stop of blood flow to a part of the brain. This happens when a blood clot forms within the vessel (known as thrombotic occlusion) or a clot originating from somewhere else blocks a blood vessel (known as embolic occlusion). Strokes can cause serious health problems, death, and affect one's quality of life. To reduce long-term damage, it is important to restore blood flow to the brain as soon as possible. The main aim of this study is to check how safe TAK-755 is, and how well adults with AIS tolerate it. Other aims are to check how well TAK-755 helps participants to manage their everyday activities and to understand whether it helps reduce the seriousness of their stroke symptoms when compared to placebo. A placebo looks like TAK-755, but does not have any medicine in it, to make sure participants do not know which treatment they are taking. The participants will receive TAK-755 or placebo once; afterwards, their health will be monitored for about 3 months (90 days). All participants, regardless of their assignment to either TAK-755 or placebo, will receive the usual treatment for AIS as per the hospital's normal practice.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-755 in Acute Ischemic Stroke

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2026-05-17

Completion Date

2027-12-06

Last Updated

2026-08-14

Healthy Volunteers

No

Interventions

BIOLOGICAL

TAK-755

TAK-755 IV infusion.

OTHER

Placebo

TAK-755 matching placebo IV infusion.

Locations (60)

HonorHealth Neurology

Scottsdale, Arizona, United States

University of Arizona

Tucson, Arizona, United States

University of California San Francisco

San Francisco, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University at Buffalo

Buffalo, New York, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

HCA Houston Healthcare - North Cypress

Cypress, Texas, United States

Neurology Consultants of Dallas, PA

Dallas, Texas, United States

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Universitair Ziekenhuis Gent (Belgium,Ghent)

Ghent, Oost-Vlaanderen, Belgium

AZ Groeninge

Kortrijk, WVL, Belgium

Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman

Liège, Belgium

Groupe sante CHC - Clinique du MontLegia

Liège, Belgium

Porto Alegre Clinical Hospital (HCPA)

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu

Botucatu, São Paulo, Brazil

Universidade Estadual de Campinas (UNICAMP)

Campinas, São Paulo, Brazil

Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - Universidade de Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Hospital Sao Paulo / Escola Paulista de Medicina da Universidade Federal de Sao Paulo (EPM/UNIFESP)

São Paulo, São Paulo, Brazil

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Nanshi Hospital of Nanyang

Nanyang, Henan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Linyi People's Hospital

Linyi, Shandong, China

Sinopharm Tongmei General Hospital

Datong, Shanxi, China

Linfen Central Hospital

Linfen, Shanxi, China

CHU Bordeaux, CHU Pellegrin

Bordeaux, Aquitaine, France

Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Raymond-Poincare

Garches, IDF, France

Bicetre Hospital

Le Kremlin-Bicêtre, IDF, France

Groupe Hospitalier Bichat Claude Bernard

Paris, IDF, France

Hopital Lariboisiere

Paris, IDF, France

Universitaetsklinikum Heidelberg (UKHD)

Heidelberg, Baden-Wurttemberg, Germany

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Klinikum Ernst von Bergmann

Potsdam, Brandenburg, Germany

Goethe-Universitaet-Universitaetsmedizin Frankfurt-Zentrum der Neurologie und Neurochirurgie (ZNN)

Frankfurt am Main, Hesse, Germany

Universitaetsmedizin Goettingen

Göttingen, Lower Saxony, Germany

Technische Universitaet Dresden-Universitaetsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

Charite Universitatsmedizin Berlin

Berlin, Germany

Second Department of Neurology, National and Kapodistrian University of Athens, "Attikon" University Hospital

Chaïdári, Attica, Greece

University Hospital of Alexandroupolis

Alexandroupoli, Evros, Greece

Athens Navy Hospital

Athens, Greece

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece

AES - AS - KLES Dr Prabhakar Kore Hospital and Medical Research Centre

Belagavi, Karnataka, India

Amrita Institute Of Medical Sciences and Research Centre

Kochi, Kerala, India

Christian Medical College, Ludhianana

Ludhiana, Punjab, India

Bangur Institute of Neurosciences

Kolkata, West Bengal, India

All India Institute of Medical Sciences, New Delhi, Department of Neurology

New Delhi, India

Saiseikai Fukuoka General Hospital

Fukuoka, Fukuoka, Japan

Fukuoka Wajiro Hospital

Fukuoka, Fukuoka, Japan

Nagano Municipal Hospital

Nagano, Nagano, Japan

Rinku General Medical Center

Izumisano, Osaka, Japan

Kotobukikai Tominaga Hospital

Osaka, Osaka, Japan

Aberdeen Royal Infirmary

Cornhill, Aberdeen, United Kingdom

Bedfordshire Hospitals NHS Foundation Trust

Luton, Bedfordshire, United Kingdom

University of Glasgow - PPDS

Glasgow, Lanarkshire, United Kingdom

NHS Greater Glasgow and Clyde, Queen Elizabeth University Hospital

Glasgow, Lanarkshire, United Kingdom

Imperial College Healthcare NHS Trust, St. Mary's Hospital

London, United Kingdom