A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke
- Registration Number
- NCT05953480
- Lead Sponsor
- Shionogi
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of redasemtide in adult participants with acute ischemic stroke (AIS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 627
- Able to initiate study intervention within 25 hours of stroke onset
- Determined by the investigator to not be eligible for recanalization thrombolysis or endovascular recanalization therapy (that is, mechanical thrombectomy, local fibrinolytic therapy) for the current stroke.
- Baseline NIHSS score of 8 to 22 (inclusive) and stable, defined as absence of an increase or decrease of ≥ 4 points within ≥ 1 hour to ≤ 3 hours between screening and baseline assessment of NIHSS score.
- 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.
- Any disease or neurological disorder that, in the opinion of the investigator, would interfere with the conduct of the study
- A severe decrease in consciousness level (defined as NIHSS item 1a score 3: Not alert, responds only with reflex motor or autonomic effects, or totally unresponsive, flaccid, and areflexic)
- Disability corresponding to a mRS score of ≥ 2 before the onset of stroke
- A history of stroke (excluding transient ischemic attack), history of or current intracranial hemorrhage, or head trauma that caused neurological effects within 90 days prior to obtaining informed consent
- Participants with an ischemic stroke in cerebellum and/or brain stem as the main infarction site
- Diagnosis of a current transient ischemic attack
- Unable to undergo either CT or MRI
- Considered by the investigator to be inappropriate to participate due to a history or complication of serious cardiovascular disease within 1 month of screening (for example, history of acute myocardial infarction, current acute myocardial infarction, uncontrollable heart failure, infective endocarditis requiring treatment, or acute aortic dissection, or requiring or likely to require hospitalization for severe arrhythmia during the study)
- Blood glucose level < 50 or > 400 milligrams/deciliter after glycemic control
- Systolic blood pressure ≥ 220 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 120 mmHg after antihypertensive treatment
- Sensitivity to any of the study interventions, or components thereof, or clinically significant drug or other severe allergy that, in the opinion of the investigator, contraindicates participation in the study
- Use of prohibited concomitant medications or therapies listed in the protocol for the treatment of current AIS
- Participants who have previously received redasemtide
- Participants who have received any investigational product within 90 days of screening
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be administered in an amount equivalent to redasemtide, as an IV infusion, once daily for 5 consecutive days during hospitalization. Redasemtide Dose A Redasemtide Redasemtide will be administered as an intravenous (IV) infusion once daily for 5 consecutive days during hospitalization. Redasemtide Dose B Redasemtide Redasemtide will be administered as an IV infusion once daily for 5 consecutive days during hospitalization.
- Primary Outcome Measures
Name Time Method Modified Rankin Scale (mRS) Score at Day 90 Day 90
- Secondary Outcome Measures
Name Time Method Number of Participants With mRS Score of 0 to 2 Day 90 mRS Score at Day 180 Day 180 Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score of 0 or 1 Days 1, 5, 30, 90, and 180 Number of Participants With Barthel Index (BI) Score ≥ 95 Day 90 Change From Baseline in NIHSS Score Baseline, Days 1, 5, 30, 90, and 180 Change From Day 5 in Stroke and Aphasia Quality of Life Scale - 39 Item Generic Version (SAQoL-39g) Score Day 5, Days 90 and 180 Patient Global Impression of Change Scale (PGI-C) Score Days 5, 90, and 180 Change From Day 5 in Patient Global Impression of Severity Scale (PGI-S) Score Day 5, Days 90 and 180 mRS Score at Day 30 Day 30 Number of Participants With BI Score ≥ 95 Days 5, 30, 90, and 180 Change From Day 5 in Short Form 36-item Health Survey (SF-36) Score Day 5, Days 90 and 180
Trial Locations
- Locations (166)
Munson Healthcare
🇺🇸Traverse City, Michigan, United States
Mayo Clinic Hospital-Rochester, St. Marys Campus - PPDS
🇺🇸Rochester, Minnesota, United States
Nuvance Health Medical Practice, PC- Neurosurgery
🇺🇸Great Neck, New York, United States
North Shore University Hospital-300 Community Dr
🇺🇸Manhasset, New York, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Ascension St. John Clinical Research Institute
🇺🇸Tulsa, Oklahoma, United States
Baylor Scott & White Research Institue
🇺🇸Dallas, Texas, United States
Social Medical Corporation hakuyoukai Kashiwaba Neurosurgical Hospital
🇯🇵Sapporo-shi, Hokkaido, Japan
Banner University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
Intercoastal Medical Group
🇺🇸Sarasota, Florida, United States
Mercyhealth Javon Bea Hospital- Riverside
🇺🇸Rockford, Illinois, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Community Hospital
🇺🇸Munster, Indiana, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Baylor Scott & White - Plano Brain & Spine Center
🇺🇸Plano, Texas, United States
University Health-University Hospital
🇺🇸San Antonio, Texas, United States
Liverpool Hospital - PPDS
🇦🇺Sydney, New South Wales, Australia
Gold Coast University Hospital
🇦🇺Southport, Queensland, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Monash Health, Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
UZ Brussel - PIN
🇧🇪Jette, Brussels, Belgium
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
AZ Sint-Jan Brugge AV
🇧🇪Brugge, West-Vlaanderen, Belgium
AZ Oostende - Damiaan
🇧🇪Oostende, West-Vlaanderen, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Clinique CHC MontLégia
🇧🇪Liège, Belgium
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Luhe Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tsinghua Changgung Hospital
🇨🇳Beijing, Beijing, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Fakultni Nemocnice Olomouc
🇨🇿Olomouc, Olomoucký Kraj, Czechia
Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2
🇨🇿Praha, Praha, Hlavní Mesto, Czechia
Nemocnice AGEL Ostrava-Vitkovice a.s.
🇨🇿Ostrava - Vitkovice, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Praha 10, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha, Czechia
Regionshospitalet Gødstrup
🇩🇰Herning, Central Jutland, Denmark
Sjællands Universitetshospital, Roskilde
🇩🇰Roskilde, Zeeland, Denmark
Helsingin yliopistollinen sairaala
🇫🇮Helsinki, Uusimaa, Finland
Universitätsklinikum Erlangen
🇩🇪Erlangen, Bayern, Germany
Varisano - Klinikum Frankfurt Höchst GmbH
🇩🇪Frankfurt am Main, Hessen, Germany
UKGM - Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen
🇩🇪Gießen, Hessen, Germany
Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
🇩🇪Minden, Nordrhein-Westfalen, Germany
Städtisches Klinikum Dresden -Friedrichstadt
🇩🇪Dresden, Sachsen, Germany
Universitatsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
Klinikum Altenburger Land GmbH
🇩🇪Altenburg, Thüringen, Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
🇩🇪Lübeck, Germany
University General Hospital of Patras
🇬🇷Patra, Achaïa, Greece
Alexandra Hospital
🇬🇷Athens, Attiki, Greece
Naval Hospital of Athens
🇬🇷Athina, Attiki, Greece
University General Hospital of Alexandroupolis
🇬🇷Alexandroupoli, Evros, Greece
University General Hospital of Heraklion
🇬🇷Heraklion, Irakleio, Greece
University General Hospital ''ATTIKON''
🇬🇷Athens, Greece
University General Hospital of Ioannina
🇬🇷Ioannina, Greece
University General Hospital of Larissa
🇬🇷Larisa, Greece
AHEPA University General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki ''Hippokratio''
🇬🇷Thessaloniki, Greece
Papageorgiou General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
Queen Mary Hospital - PPDS
🇭🇰Hong Kong, Hong Kong
Prince of Wales Hospital
🇭🇰New Territories, Hong Kong
Princess Margaret Hospital - Hong Kong
🇭🇰New Territories, Hong Kong
Pécsi Tudomanyegyetem - Vasvari Pal u.
🇭🇺Pécs, Baranya, Hungary
Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz és Egyetemi Oktatokorhaz
🇭🇺Miskolc, Borsod-Abaúj-Zemplén, Hungary
Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus
🇭🇺Debrecen, Hajdú-Bihar, Hungary
Kistarcsai Flór Ferenc Kórház
🇭🇺Kistarcsa, Pest, Hungary
Szent Damjan Gorogkatolikus Korhaz
🇭🇺Kisvárda, Szabolcs-Szatmár-Bereg, Hungary
Váci Jávorszky Ödön Kórház
🇭🇺Vác, Pest, Hungary
Semmelweis Egyetem
🇭🇺Budapest, Hungary
Budapesti Bajcsy-Zsilinszky Korhaz es Rendelointezet
🇭🇺Budapest, Hungary
Eszak-Pesti Centrumkorhaz -Honvedkorhaz
🇭🇺Budapest, Hungary
Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika
🇭🇺Budapest, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladár Egyetemi Oktató Kórház
🇭🇺Győr, Hungary
Veszprém Vármegyei Csolnoky Ferenc Kórház
🇭🇺Veszprém, Hungary
Assuta Ashdod Medical Center
🇮🇱Ashdod, HaDarom, Israel
Hillel Yaffe Medical Center
🇮🇱Hadera, Haifa, Israel
Meir Medical Center
🇮🇱Kfar Sava, HaMerkaz, Israel
Shaare Zedek Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
Hadassah Medical Center - PPDS
🇮🇱Jerusalem, Yerushalayim, Israel
Galilee Medical Center
🇮🇱Nahariya, HaZafon, Israel
Tel Aviv Sourasky Medical Center - PPDS
🇮🇱Tel Aviv-Yafo, Tel-Aviv, Israel
Barzilai Medical Center
🇮🇱Ashkelon, Israel
Kimitsu Chuo Hospital
🇯🇵Kisaratsu, Chiba, Japan
Takayama Red Cross Hospital
🇯🇵Takayama-Shi, Gifu, Japan
Rambam Medical Center - PPDS
🇮🇱Haifa, Israel
Sheba Medical Center - PPDS
🇮🇱Ramat-Gan, Israel
ZIV Medical Center
🇮🇱Safed, Israel
National Hospital Organization Toyohashi Medical Center
🇯🇵Toyohashi-Shi, Aichi, Japan
Mazda Hospital of Mazda Motor Corporation
🇯🇵Aki-gun, Hiroshima, Japan
National Hospital Organization Higashihiroshima Medical Center
🇯🇵Higashihiroshima-Shi, Hiroshima, Japan
Shinsuma General Hospital
🇯🇵Kobe-Shi Suma-Ku, Hyôgo, Japan
Hyogo Medical University Hospital
🇯🇵Nishinomiya-Shi, Hyôgo, Japan
Seisho Hospital
🇯🇵Odawara-Shi, Kanagawa, Japan
National Hospital Organization Yokohama Medical Center
🇯🇵Yokohama-Shi, Kanagawa, Japan
National Hospital Organization Beppu Medical Center
🇯🇵Beppu-Shi, Oita, Japan
Rinku General Medical Center
🇯🇵Izumisano-Shi, Osaka, Japan
National Hospital Organization Kure Medical Center and Chugoku Cancer Center
🇯🇵Kure-Shi, Hiroshima, Japan
Shin Komonji Hospital
🇯🇵Kitakyushu-Shi, Hukuoka, Japan
Our Lady of the Snow Social Medical Corporation St. Mary's Hospital
🇯🇵Kurume-Shi, Hukuoka, Japan
JA Toride Medical Center
🇯🇵Toride-Shi, Ibaraki, Japan
Tsukuba Medical Center Hospital
🇯🇵Tsukuba-Shi, Ibaraki, Japan
Osaka University Hospital
🇯🇵Suita-Shi, Osaka, Japan
National Hospital Organization Hamada Medical Center
🇯🇵Hamada-Shi, Shimane, Japan
Chutoen General Medical Center
🇯🇵Kakegawa-Shi, Sizuoka, Japan
Shizuoka City Shizuoka Hospital
🇯🇵Shizuoka-Shi Aoi-Ku, Sizuoka, Japan
Federation of National Public Service Personnel Mutual Aid Associations Mishuku Hospital
🇯🇵Meguro-Ku, Tokyo, Japan
Ome Medical Center
🇯🇵Ome-Shi, Tokyo, Japan
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Tokyo Metropolitan Bokutoh Hospital
🇯🇵Sumida-ku, Tokyo, Japan
Sanyudo Hospital
🇯🇵Yonezawa-Shi, Yamagata, Japan
Fukui Prefectural Hospital
🇯🇵Fukui, Japan
Social Medical Corporation Foundation Chiyuukai Fukuoka Wajiro Hospital
🇯🇵Fukuoka, Japan
Kotobuki Social Medical Corporation Tominaga Hospital
🇯🇵Osaka, Japan
National Hospital Organization Osaka National Hospital
🇯🇵Osaka, Japan
Sainokuni Higashiomiya Medical Center
🇯🇵Saitama, Japan
National Cerebral and Cardiovascular Center
🇯🇵Suita-Shi, Ôsaka, Japan
Keimyung University Dongsan Hospital
🇰🇷Daegu, Daegu Gwang'yeogsi, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang-si, Gyeonggido, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Hanyang University Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital for Cerebrovascular Diseases Sveti Sava
🇷🇸Belgrade, Serbia
University Clinical Center of Serbia - Pasterova 2 - PPDS
🇷🇸Belgrade, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
University Clinical Center Nis
🇷🇸Nis, Serbia
Clinical Centre of Vojvodina
🇷🇸Novi Sad, Serbia
General Hospital Dr. Djordje Joanovic - Zrenjanin
🇷🇸Zrenjanin, Serbia
National University Hospital- Singapore
🇸🇬Singapore, Singapore
Hospital Universitario de Bellvitge
🇪🇸L'hospitalet de Llobregat, Barcelona, Spain
Corporacio Sanitaria Parc Tauli
🇪🇸Sabadell, Barcelona, Spain
Hospital Mutua de Terrassa
🇪🇸Terrassa, Barcelona, Spain
CHUVI - H.U. Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital Universitario A Coruña
🇪🇸a Coruña, Spain
Hospital Universitario Torrecardenas
🇪🇸Almeria, Spain
Hospital Universitario de Badajoz
🇪🇸Badajoz, Spain
Hospital de La Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron - PPDS
🇪🇸Barcelona, Spain
Hospital Universitario Virgen de La Arrixaca
🇪🇸El Palmar, Spain
Hospital Universitari Arnau de Vilanova
🇪🇸Lleida, Spain
Hospital Universitario Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Charing Cross Hospital
🇬🇧London, London, City Of, United Kingdom
Northwick Park Hospital
🇬🇧Harrow, Middlesex, United Kingdom
The Royal London Hospital
🇬🇧London, Middlesex, United Kingdom
National Hospital for Neurology & Neurosurgery
🇬🇧London, Middlesex, United Kingdom
Fairfield General Hospital - PPDS
🇬🇧Bury, United Kingdom
Hospital Universitari de Girona Dr Josep Trueta
🇪🇸Girona, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario La Paz - PPDS
🇪🇸Madrid, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Universitari de Tarragona Joan XXIII
🇪🇸Tarragona, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Spain
Aberdeen Royal Infirmary - PPDS
🇬🇧Aberdeen, Aberdeenshire, United Kingdom
Luton and Dunstable Hospital
🇬🇧Luton, Bedfordshire, United Kingdom
Royal Berkshire Hospital NHS Foundation Trust
🇬🇧Reading, Berkshire, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle, United Kingdom