> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-2b-randomized-double-blind-study-of-redasemtide-s-bb3690f9-5cfd-4af6-bcf5-e72f43e38048 > Record changed: 2026-10-13 # A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke NCT05953480 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) Participants 680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) Lead sponsor Shionogi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) Start date 2023-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) Number of sites 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Acronym** Revive Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Short title** A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## Dates **Completion date** 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **First posted** 2023-07-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Registry last updated** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Primary completion date** 2026-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Start date** 2023-07-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## Size and sites **Actual participants** 680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Participants** 680 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Number of sites** 150 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Lead sponsor** Shionogi Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## Identifiers **Registry ID** NCT05953480 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **ClinicalTrials.gov ID** NCT05953480 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## Outcomes ### Primary outcomes 1. Modified Rankin Scale (mRS) Score at Day 90 Timeframe: Day 90 ### Secondary outcomes 1. Number of Participants With mRS Score of 0 to 2 Timeframe: Day 90 2. Number of Participants With Barthel Index (BI) Score ≥ 95 Timeframe: Day 90 3. mRS Score at Day 30 Timeframe: Day 30 4. mRS Score at Day 180 Timeframe: Day 180 5. Number of Participants With National Institutes of Health Stroke Scale (NIHSS) Score of 0 or 1 Timeframe: Days 1, 5, 30, 90, and 180 6. Change From Baseline in NIHSS Score Timeframe: Baseline, Days 1, 5, 30, 90, and 180 7. Number of Participants With BI Score ≥ 95 Timeframe: Days 5, 30, and 180 8. Change From Day 5 in Short Form 36-item Health Survey (SF-36) Score Timeframe: Day 5, Days 90 and 180 9. Change From Day 5 in Stroke and Aphasia Quality of Life Scale - 39 Item Generic Version (SAQoL-39g) Score Timeframe: Day 5, Days 90 and 180 10. Patient Global Impression of Change Scale (PGI-C) Score Timeframe: Days 5, 90, and 180 11. Change From Day 5 in Patient Global Impression of Severity Scale (PGI-S) Score Timeframe: Day 5, Days 90 and 180 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - 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. Key Exclusion Criteria: - 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 computed tomography or magnetic resonance imaging - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## Sites - Banner University of Arizona Medical CenterTucson, United States - Intercoastal Medical GroupSarasota, United States - Augusta UniversityAugusta, United States - Mercyhealth Javon Bea Hospital- RiversideRockford, United States - Community HospitalMunster, United States - Sinai Hospital of BaltimoreBaltimore, United States - Munson HealthcareTraverse City, United States - Mayo Clinic Hospital-Rochester, St. Mary's Campus - PPDSRochester, United States - North Shore University Hospital-300 Community DrManhasset, United States - Nuvance Health Medical Practice, PC- NeurosurgeryPoughkeepsie, United States - Summa Health System - Akron CampusAkron, United States - Ohio State University Wexner Medical CenterColumbus, United States - Ascension St. John Clinical Research InstituteTulsa, United States - Baylor University Medical Center - 3500 Gaston AveDallas, United States - Houston Methodist HospitalHouston, United States - Baylor Scott & White - Plano Brain & Spine CenterPlano, United States - University Health-University HospitalSan Antonio, United States - Liverpool Hospital - PPDSSydney, Australia - Gold Coast University HospitalSouthport, Australia - Royal Adelaide HospitalAdelaide, Australia - The Alfred HospitalMelbourne, Australia - Royal Melbourne HospitalParkville, Australia - Fiona Stanley HospitalMurdoch, Australia - UZ Brussel - PINJette, Belgium - UZ GentGhent, Belgium And 125 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## References ### Other registry identifiers - 2022-501890-38-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05953480) ## Related records ### Drugs (1) - [Redasemtide](https://trialight.com/data/asset/redasemtide-dbd9e8a7-b863-4e55-ad5a-589d33d00153.md) ### Lead sponsors (1) - [Shionogi](https://trialight.com/data/company/shionogi-b43f8414-7488-436b-b4cd-1fb0330070e3.md) ### Conditions (2) - [Ischemic stroke](https://trialight.com/data/condition/ischemic-stroke-22957443-39c1-55ea-8c6d-d5be07d42dc0.md) - [Transient ischemic attack](https://trialight.com/data/condition/transient-ischemic-attack-4355dfad-752a-55bb-8d3e-cd43c9c8144b.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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