REvive
Research type
Research Study
Full title
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 who are not eligible for tissue plasminogen activator or thrombectomy
IRAS ID
1007707
Contact name
Rob Cassels
Contact email
Sponsor organisation
Shionogi B.V.
Clinicaltrials.gov Identifier
Research summary
The indication of this study is acute ischemic stroke (AIS). An AIS is the sudden loss of blood flow to an area of the brain resulting in the loss of neurologic function, meaning there is a problem with the functioning of the nervous system and how the brain and body sends and/or receives signals.
This study is being performed to evaluate a potential new medicine S-005151, also known as redasemtide, in patients who are not eligible for standard of care treatments such as thrombolysis (treatment to dissolve a blood clot) or thrombectomy (surgery to remove a blood clot). The study drug has been evaluated in two phase 1 studies in healthy adult participants, and in one phase 2 study in elderly participants with AIS.
The study Sponsor is Shionogi B.V.
Approximately 627 patients will be enrolled into the study globally. Patients will be assigned randomly to receive S-005151 or placebo (a substance that looks just like the experimental medication but has no active ingredient).
Participants will be asked to attend approximately 8 visits (5 days of hospitalisation and 3 visits to the study site) over a 180-day period. Study procedures will include vital signs, physical examination, computed tomography (CT) or magnetic resonance imaging (MRI) scan, electrocardiogram (ECG), and blood samples.REC name
London - Harrow Research Ethics Committee
REC reference
23/LO/0683
Date of REC Opinion
21 Dec 2023
REC opinion
Further Information Favourable Opinion