A Phase 2b, Multinational, Randomized, Double-blind Study to Investigate the Efficacy and Safety of Redasemtide (S-005151) Compared With Placebo in Adult Participants With Acute Ischemic Stroke

Status: Recruiting
Location: See all (174) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS). This study consists of 2 cohorts, Cohort A and Cohort B. Cohort A (redasemtide or placebo) will enroll participants who are ineligible for systemic thrombolysis and/or mechanical recanalization therapy. Cohort B (redasemtide or placebo) will enroll participants who are eligible to receive or who have received systemic thrombolysis and/or mechanical recanalization therapy as standard of care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Able to initiate study intervention within 25 hours of stroke onset

• Cohort A: Determined by the investigator to not be eligible for systemic thrombolysis and/or mechanical recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy as per local standard of care) for the current stroke.

• Cohort B: Determined by the investigator to be eligible for systemic thrombolysis and/or mechanical recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy as per local standard of care) for the current stroke.

• Cohort A: If a participant is not eligible for systemic thrombolysis and/or mechanical recanalization therapy, screening and baseline NIHSS score of 6 to 22 is required (inclusive) and must be stable, defined as absence of an increase or decrease of ≥4 points within ≥1 hour to ≤3 hours of screening, and NIHSS score should be 6 to 22 at baseline.

• Cohort B: In a participant who is eligible to receive or has received concomitant systemic thrombolysis and/or mechanical recanalization therapy, the NIHSS score must be 6 to 22 at screening prior to systemic thrombolysis and/or mechanical recanalization therapy and the second/baseline NIHSS score must be 6 to 22 and should be done after systemic thrombolysis and/or mechanical recanalization therapy.

• Medically stable at the time of enrollment except for primary disease and complications associated with it, according to the judgment of the investigator. In addition, hospitalization during the Follow-up Period is not anticipated, and the participant appears likely to be able to complete the study. Medically stable is defined as disease not requiring significant change in therapy for 3 months following enrollment.

Locations
United States
Arizona
Banner University of Arizona Medical Center
RECRUITING
Tucson
Florida
Intercoastal Medical Group
RECRUITING
Sarasota
Georgia
Augusta University
RECRUITING
Augusta
Illinois
Mercyhealth Javon Bea Hospital- Riverside
RECRUITING
Rockford
Indiana
Community Hospital
ACTIVE_NOT_RECRUITING
Munster
Maryland
Sinai Hospital of Baltimore
RECRUITING
Baltimore
Michigan
Munson Healthcare
RECRUITING
Traverse City
Minnesota
Mayo Clinic Hospital-Rochester, St. Mary's Campus - PPDS
RECRUITING
Rochester
New York
North Shore University Hospital-300 Community Dr
ACTIVE_NOT_RECRUITING
Manhasset
Nuvance Health Medical Practice, PC- Neurosurgery
ACTIVE_NOT_RECRUITING
Poughkeepsie
Ohio
Summa Health System - Akron Campus
ACTIVE_NOT_RECRUITING
Akron
Ohio State University Wexner Medical Center
RECRUITING
Columbus
Oklahoma
Ascension St. John Clinical Research Institute
RECRUITING
Tulsa
Texas
Baylor University Medical Center - 3500 Gaston Ave
ACTIVE_NOT_RECRUITING
Dallas
Houston Methodist Hospital
ACTIVE_NOT_RECRUITING
Houston
Baylor Scott & White - Plano Brain & Spine Center
ACTIVE_NOT_RECRUITING
Plano
University Health-University Hospital
RECRUITING
San Antonio
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Monash Health, Monash Medical Centre
ACTIVE_NOT_RECRUITING
Clayton
The Alfred Hospital
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Murdoch
Royal Melbourne Hospital
RECRUITING
Parkville
Gold Coast University Hospital
RECRUITING
Southport
Liverpool Hospital - PPDS
RECRUITING
Sydney
Belgium
AZ Sint-Jan Brugge AV
RECRUITING
Bruges
UZ Gent
RECRUITING
Ghent
UZ Brussel - PIN
ACTIVE_NOT_RECRUITING
Jette
UZ Leuven
RECRUITING
Leuven
Clinique CHC MontLégia
COMPLETED
Liège
AZ Oostende - Damiaan
RECRUITING
Ostend
China
Beijing Luhe Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Tiantan Hospital, Capital Medical University
RECRUITING
Beijing
Beijing Tsinghua Changgung Hospital
RECRUITING
Beijing
Xuanwu Hospital Capital Medical University
RECRUITING
Beijing
The First Hospital of Jilin University
RECRUITING
Changchun
Nanjing First Hospital
RECRUITING
Nanjing
Denmark
Regionshospitalet Gødstrup
WITHDRAWN
Herning
Sjællands Universitetshospital, Roskilde
ACTIVE_NOT_RECRUITING
Roskilde
Finland
Helsingin yliopistollinen sairaala
RECRUITING
Helsinki
Germany
Klinikum Altenburger Land GmbH
RECRUITING
Altenburg
Städtisches Klinikum Dresden -Friedrichstadt
COMPLETED
Dresden
Universitätsklinikum Erlangen
COMPLETED
Erlangen
Varisano - Klinikum Frankfurt Höchst GmbH
RECRUITING
Frankfurt Am Main
UKGM - Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen
RECRUITING
Giessen
Universitatsklinikum Leipzig
RECRUITING
Leipzig
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
ACTIVE_NOT_RECRUITING
Lübeck
Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
COMPLETED
Minden
Greece
University General Hospital of Alexandroupolis
RECRUITING
Alexandroupoli
Alexandra Hospital
RECRUITING
Athens
Naval Hospital of Athens
RECRUITING
Athens
University General Hospital ''ATTIKON''
RECRUITING
Athens
University General Hospital of Heraklion
RECRUITING
Heraklion
University General Hospital of Ioannina
RECRUITING
Ioannina
University General Hospital of Larissa
RECRUITING
Larissa
University General Hospital of Patras
RECRUITING
Pátrai
AHEPA University General Hospital of Thessaloniki
RECRUITING
Thessaloniki
General Hospital of Thessaloniki ''G. Papanikolaou''
ACTIVE_NOT_RECRUITING
Thessaloniki
General Hospital of Thessaloniki ''Hippokratio''
COMPLETED
Thessaloniki
Papageorgiou General Hospital of Thessaloniki
ACTIVE_NOT_RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Queen Mary Hospital - PPDS
RECRUITING
Hong Kong
Princess Margaret Hospital - Hong Kong
RECRUITING
Kwai Chung
Prince of Wales Hospital
RECRUITING
Shatin
Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
COMPLETED
Budapest
Eszak-Pesti Centrumkorhaz -Honvedkorhaz
RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika
RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
COMPLETED
Debrecen
Gyor-Moson-Sopron Varmegyei Petz Aladár Egyetemi Oktató Kórház
RECRUITING
Győr
Kistarcsai Flór Ferenc Kórház
RECRUITING
Kistarcsa
Szent Damjan Gorogkatolikus Korhaz
RECRUITING
Kisvárda
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz és Egyetemi Oktatokorhaz
RECRUITING
Miskolc
Pécsi Tudomanyegyetem - Vasvari Pal u.
RECRUITING
Pécs
Váci Jávorszky Ödön Kórház
COMPLETED
Vác
Veszprém Vármegyei Csolnoky Ferenc Kórház
ACTIVE_NOT_RECRUITING
Veszprém
Israel
Assuta Ashdod Medical Center
ACTIVE_NOT_RECRUITING
Ashdod
Barzilai Medical Center
RECRUITING
Ashkelon
Hillel Yaffe Medical Center
RECRUITING
Hadera
Rambam Medical Center - PPDS
RECRUITING
Haifa
Hadassah Medical Center - PPDS
RECRUITING
Jerusalem
Shaare Zedek Medical Center
ACTIVE_NOT_RECRUITING
Jerusalem
Meir Medical Center
ACTIVE_NOT_RECRUITING
Kfar Saba
Galilee Medical Center
RECRUITING
Nahariya
Sheba Medical Center - PPDS
RECRUITING
Ramat Gan
ZIV Medical Center
RECRUITING
Safed
Tel Aviv Sourasky Medical Center - PPDS
RECRUITING
Tel Aviv
Japan
Mazda Hospital of Mazda Motor Corporation
WITHDRAWN
Aki-gun
Shizuoka City Shizuoka Hospital
RECRUITING
Aoi-ku
National Hospital Organization Beppu Medical Center
RECRUITING
Beppu-shi
Fukui Prefectural Hospital
RECRUITING
Fukui-shi
Social Medical Corporation The Chiyukai Foundation Fukuoka Wajiro Hospital
RECRUITING
Fukuoka
National Hospital Organization Hamada Medical Center
RECRUITING
Hamada-shi
Japan Organization of Occupational Health and Safety Hamamatsu Rosai Hospital
RECRUITING
Hamamatsu
National Hospital Organization Higashihiroshima Medical Center
RECRUITING
Higashihiroshima-shi
Rinku General Medical Center
RECRUITING
Izumisano
Chutoen General Medical Center
RECRUITING
Kakegawa-shi
Kimitsu Chuo Hospital
RECRUITING
Kisarazu
Shin Komonji Hospital
RECRUITING
Kitakyushu-shi
Shinsuma General Hospital
RECRUITING
Kobe
Shin-Kuki General Hospital
RECRUITING
Kuki-shi
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
RECRUITING
Kure-shi
Our Lady of the Snow Social Medical Corporation St. Mary's Hospital
RECRUITING
Kurume-shi
Misyuku Hospital
RECRUITING
Meguro-ku
Hyogo Medical University Hospital
RECRUITING
Nishinomiya-shi
Seisho Hospital
RECRUITING
Odawara-shi
Ome Medical Center
WITHDRAWN
Ome-shi
Omuta City Hospital
RECRUITING
Omuta-shi
National Hospital Organization Osaka National Hospital
RECRUITING
Osaka
Tominaga Hospital
RECRUITING
Osaka
Sainokuni Higashiomiya Medical Center
WITHDRAWN
Saitama
Social Medical Corporation Hakuyoukai Kashiwaba Neurosurgical Hospital
WITHDRAWN
Sapporo
Tokyo Women's Medical University Hospital
WITHDRAWN
Shinjuku-ku
National Cerebral and Cardiovascular Center
RECRUITING
Suita-shi
Osaka University Hospital
RECRUITING
Suita-shi
Tokyo Metropolitan Bokutoh Hospital
WITHDRAWN
Sumida-ku
Japanese Red Cross Takayama Hospital
RECRUITING
Takayama-shi
JA Toride Medical Center
WITHDRAWN
Toride-shi
National Hospital Organization Toyohashi Medical Center
RECRUITING
Toyohashi
Tsukuba Medical Center Hospital
WITHDRAWN
Tsukuba
National Hospital Organization Yokohama Medical Center
RECRUITING
Yokohama
Sanyudo Hospital
COMPLETED
Yonezawa-shi
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Inje University Ilsan Paik Hospital
RECRUITING
Goyang-si
Hanyang University Medical Center
RECRUITING
Seoul
Kyung Hee University Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Serbia
Hospital for Cerebrovascular Diseases Sveti Sava
RECRUITING
Belgrade
Military Medical Academy
ACTIVE_NOT_RECRUITING
Belgrade
University Clinical Center of Serbia - Pasterova 2 - PPDS
RECRUITING
Belgrade
General Hospital Bor
ACTIVE_NOT_RECRUITING
Bor
General Hospital Cuprija
ACTIVE_NOT_RECRUITING
Ćuprija
University Clinical Center Kragujevac
WITHDRAWN
Kragujevac
General Hospital Leskovac
RECRUITING
Leskovac
University Clinical Center Nis
RECRUITING
Niš
Clinical Centre of Vojvodina
RECRUITING
Novi Sad
Health Center Uzice
ACTIVE_NOT_RECRUITING
Užice
Health Center Valjevo
RECRUITING
Valjevo
General Hospital Dr. Djordje Joanovic - Zrenjanin
RECRUITING
Zrenjanin
Singapore
National University Hospital- Singapore
RECRUITING
Singapore
Singapore General Hospital (SGH)
RECRUITING
Singapore
Spain
Hospital Universitario A Coruña
RECRUITING
A Coruña
Hospital Universitario Torrecardenas
RECRUITING
Almería
Hospital Universitario de Badajoz
ACTIVE_NOT_RECRUITING
Badajoz
Hospital de La Santa Creu i Sant Pau
RECRUITING
Barcelona
Hospital Universitario Vall d'Hebron - PPDS
ACTIVE_NOT_RECRUITING
Barcelona
Hospital Universitario Virgen de La Arrixaca
RECRUITING
El Palmar
Hospital Universitari de Girona Dr Josep Trueta
RECRUITING
Girona
Hospital Universitario de Bellvitge
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Hospital Universitari Arnau de Vilanova
RECRUITING
Lleida
Hospital Clinico San Carlos
COMPLETED
Madrid
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario La Paz - PPDS
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital Universitario Virgen de la Victoria
RECRUITING
Málaga
Corporacio Sanitaria Parc Tauli
RECRUITING
Sabadell
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitari de Tarragona Joan XXIII
ACTIVE_NOT_RECRUITING
Tarragona
Hospital Mutua de Terrassa
ACTIVE_NOT_RECRUITING
Terrassa
Hospital Universitari i Politecnic La Fe de Valencia
RECRUITING
Valencia
CHUVI - H.U. Alvaro Cunqueiro
RECRUITING
Vigo
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
United Kingdom
Aberdeen Royal Infirmary - PPDS
RECRUITING
Aberdeen
Fairfield General Hospital - PPDS
RECRUITING
Bury
Northwick Park Hospital
RECRUITING
Harrow
Leicester Royal Infirmary
RECRUITING
Leicester
Charing Cross Hospital
RECRUITING
London
King's College Hospital
RECRUITING
London
National Hospital for Neurology & Neurosurgery
RECRUITING
London
The Royal London Hospital
RECRUITING
London
Luton and Dunstable Hospital
RECRUITING
Luton
Royal Victoria Infirmary
RECRUITING
Newcastle
Royal Berkshire Hospital NHS Foundation Trust
RECRUITING
Reading
Contact Information
Primary
Shionogi Clinical Trials Administrator Clinical Support Help Line
Shionogiclintrials-admin@shionogi.co.jp
1-800-849-9707
Time Frame
Start Date: 2023-07-14
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 849
Treatments
Experimental: Redasemtide Dose A
Redasemtide will be administered as an intravenous (IV) infusion once daily for 5 consecutive days during hospitalization.
Experimental: Redasemtide Dose B
Redasemtide will be administered as an IV infusion once daily for 5 consecutive days during hospitalization.
Placebo_comparator: Placebo
Placebo will be administered in an amount equivalent to redasemtide, as an IV infusion, once daily for 5 consecutive days during hospitalization.
Related Therapeutic Areas
Sponsors
Leads: Shionogi

This content was sourced from clinicaltrials.gov