A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke
Completed · Phase 2 · Has a placebo group
Conditions studied: Acute Ischemic Stroke
In brief
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.
Key facts
- Study ID
- NCT05953480
- Run by
- Shionogi
- People needed
- 680
- Starts
- 2023-07-14
- Expected to finish
- 2026-06-15
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Omuta City Hospital — Omuta-Shi, Fukuoka, Japan
- Japanese Red Cross Takayama Hospital — Takayama-Shi, Gifu, Japan
- National Hospital Organization Higashihiroshima Medical Center — Higashihiroshima-Shi, Hiroshima, Japan
- National Hospital Organization Kure Medical Center and Chugoku Cancer Center — Kure-Shi, Hiroshima, Japan
- Fukui Prefectural Hospital — Fukui-shi, Hukui, Japan
- Our Lady of the Snow Social Medical Corporation St. Mary's Hospital — Kurume-Shi, Hukuoka, Japan
- Shinsuma General Hospital — Kobe, Hyôgo, Japan
- Banner University of Arizona Medical Center — Tucson, Arizona, United States
- Intercoastal Medical Group — Sarasota, Florida, United States
- Augusta University — Augusta, Georgia, United States
- Mercyhealth Javon Bea Hospital- Riverside — Rockford, Illinois, United States
- Community Hospital — Munster, Indiana, United States
- Sinai Hospital of Baltimore — Baltimore, Maryland, United States
- Munson Healthcare — Traverse City, Michigan, United States
- Mayo Clinic Hospital-Rochester, St. Mary's Campus - PPDS — Rochester, Minnesota, United States
- North Shore University Hospital-300 Community Dr — Manhasset, New York, United States
- Nuvance Health Medical Practice, PC- Neurosurgery — Poughkeepsie, New York, United States
- Summa Health System - Akron Campus — Akron, Ohio, United States
- Ohio State University Wexner Medical Center — Columbus, Ohio, United States
- Ascension St. John Clinical Research Institute — Tulsa, Oklahoma, United States
- Baylor University Medical Center - 3500 Gaston Ave — Dallas, Texas, 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
- Shin Komonji Hospital — Kitakyushu-Shi, Fukuoka, Japan
Full record on ClinicalTrials.gov
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