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Redasemtide Dose A for Stroke (REvive Trial)

Phase 2

Recruiting

Research Sponsored by Shionogi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Baseline NIHSS score of 8 to 22 (inclusive) and stable

Able to initiate study intervention within 25 hours of stroke onset

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 1, 5, 30, 90, and 180

Awards & highlights

REvive Trial Summary

This trial aims to investigate whether redasemtide is effective and safe for adults who have experienced a stroke caused by a lack of blood flow to the brain.

Who is the study for?

This trial is for adults who've had an ischemic stroke within the last 25 hours and are not suitable for clot removal treatments. They should have a moderate level of stroke severity, be medically stable except for their stroke, and likely to complete the study without needing hospitalization.Check my eligibility

What is being tested?

The trial is testing Redasemtide's effectiveness and safety in treating acute ischemic strokes compared to a placebo. Participants will randomly receive either Redasemtide or a placebo without knowing which one they're getting (double-blind).See study design

What are the potential side effects?

While specific side effects of Redasemtide aren't listed here, common side effects from similar trials may include headache, nausea, allergic reactions, bleeding complications, or other drug-related adverse events.

REvive Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My stroke severity score is between 8 and 22 and hasn't changed recently.

Select...

I can start the study treatment within 25 hours after my stroke.

REvive Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 1, 5, 30, 90, and 180

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 1, 5, 30, 90, and 180

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 5, 30, 90, and 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Modified Rankin Scale (mRS) Score at Day 90

Secondary outcome measures

Change From Baseline in NIHSS Score

Change From Day 5 in Patient Global Impression of Severity Scale (PGI-S) Score

Change From Day 5 in Short Form 36-item Health Survey (SF-36) Score

+8 more

REvive Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Redasemtide Dose BExperimental Treatment1 Intervention

Redasemtide will be administered as an IV infusion once daily for 5 consecutive days during hospitalization.

Group II: Redasemtide Dose AExperimental Treatment1 Intervention

Redasemtide will be administered as an intravenous (IV) infusion once daily for 5 consecutive days during hospitalization.

Group III: PlaceboPlacebo Group1 Intervention

Placebo will be administered in an amount equivalent to redasemtide, as an IV infusion, once daily for 5 consecutive days during hospitalization.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

ShionogiLead Sponsor

116 Previous Clinical Trials

40,859 Total Patients Enrolled

1 Trials studying Stroke

270 Patients Enrolled for Stroke

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different sites is this study currently being conducted?

"In total, there are 54 active recruitment sites for this clinical trial. Notable locations include the Japanese Red Cross Takayama Hospital in Gifu, National Hospital Organization Higashihiroshima Medical Center in Hiroshima, and Sanyudo Hospital in Yamagata among others."

Answered by AI

Has the FDA authorized the dosage of Redasemtide?

"Our team at Power has assessed the safety of Redasemtide Dose A as a 2 on our scale due to the ongoing Phase 2 trial, where existing data supports its safety profile but lacks evidence regarding efficacy."

Answered by AI

Are new participants currently being welcomed to enroll in this trial?

"Indeed, the details on clinicaltrials.gov affirm that this research endeavor is presently in search of suitable candidates. The trial appeared online on July 14th, 2023, and has been periodically updated until February 9th, 2024. A total of 627 participants are sought from a network spanning across 54 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke

2023. "A Phase 2b, Randomized, Double-blind Study of Redasemtide (S-005151) in Adult Participants With Acute Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05953480.

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