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NCT05953480 · ClinicalTrials.gov registry record · Phase 2
A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke
A Phase 2 study of Acute Ischemic Stroke, sponsored by Shionogi.
- Active
- Registry status
- Phase 2
- Development phase
- 680
- Enrollment target
- 20
- Study locations
NCT05953480: Active Phase 2 study of Acute Ischemic Stroke, sponsored by Shionogi.
NCT05953480 is a Phase 2 study of Acute Ischemic Stroke that is active but no longer recruiting, run by Shionogi. The registered enrollment target is 680 participants, above the 325-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (109% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05953480, a Phase 2 study of Acute Ischemic Stroke, is active but no longer recruiting, sponsored by Shionogi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 680 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Redasemtide
Study Locations (20)
Texas
- Baylor University Medical Center - 3500 Gaston Ave - Dallas
- Houston Methodist Hospital - Houston
- Baylor Scott & White - Plano Brain & Spine Center - Plano
- University Health-University Hospital - San Antonio
New York
- North Shore University Hospital-300 Community Dr - Manhasset
- Nuvance Health Medical Practice, PC- Neurosurgery - Poughkeepsie
Ohio
- Summa Health System - Akron Campus - Akron
- Ohio State University Wexner Medical Center - Columbus
Arizona
- Banner University of Arizona Medical Center - Tucson
Florida
- Intercoastal Medical Group - Sarasota
Georgia
- Augusta University - Augusta
Illinois
- Mercyhealth Javon Bea Hospital- Riverside - Rockford
Indiana
- Community Hospital - Munster
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 680 participants |
| Start Date | 2023-07-14 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 2 |
What the registry record for NCT05953480 still lists
NCT05953480 is an interventional study that assigns participants to a tested intervention. The registered 680 participants enrollment target is mid-sized for trials with a published cap, above the 325-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (109% higher).
The record links to 1 condition, with Acute Ischemic Stroke appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05953480 names 20 study sites across 15 states, led by Texas, New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT05953480 about?
NCT05953480 is a clinical study titled "A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke". 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...
What is the current status of trial NCT05953480?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 680 participants. The study started on 2023-07-14. Estimated completion is 2026-03-31.
What conditions does trial NCT05953480 study?
This clinical trial studies the following conditions: Acute Ischemic Stroke.
What interventions are being tested in trial NCT05953480?
The interventions under investigation include: Placebo (DRUG), Redasemtide (BIOLOGICAL).
Who is sponsoring clinical trial NCT05953480?
This trial is sponsored by Shionogi, which has 54 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05953480 being conducted?
This trial has 20 study locations across Arizona, Florida, Georgia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05953480's enrollment target sits among peer trials
680 5th of 25 higher than 21 of 25 other Acute Ischemic Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Ischemic Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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