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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 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.

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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

Acute Ischemic Stroke

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

FieldValue
Enrollment Target 680 participants
Start Date 2023-07-14
Est. Completion 2026-03-31
Phase Phase 2

Sponsor

Shionogi

54 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05953480

The ClinicalTrials.gov registry entry for NCT05953480 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 680 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 325-participant average among 25 other Acute Ischemic Stroke trials with a reported enrollment target (109% higher). The listed sponsor is Shionogi, which has 54 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.