What is the mechanism of action of this treatment?

Common treatments for stroke, such as thrombolytics and neuroprotective agents, primarily aim to restore blood flow and protect brain tissue. Thrombolytics like tPA dissolve clots to re-establish blood flow, while neuroprotective agents help shield brain cells from further damage. Regenerative therapies, like Redasemtide, are designed to promote tissue repair and regeneration, which is vital for improving recovery and reducing long-term disability in stroke patients. These mechanisms are crucial as they not only address the immediate blockage but also enhance the brain's ability to heal and regain function.

What side effects are associated with this type of intervention?

Common treatments for acute ischemic stroke include thrombolytics like alteplase, antiplatelet agents, and anticoagulants. Thrombolytics can cause bleeding complications, including intracranial hemorrhage. Antiplatelet agents, such as aspirin, may lead to gastrointestinal bleeding and ulcers. Anticoagulants, like warfarin, carry risks of bleeding and require regular monitoring. Treatments similar to Redasemtide, which focus on tissue repair and regeneration, are still under investigation, but potential side effects could include immune reactions or local site reactions. As with any new treatment, ongoing trials are essential to fully understand the safety profile.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke, primarily focusing on thrombolytic agents like tissue plasminogen activator (tPA) for acute ischemic stroke, which helps dissolve blood clots. Other treatments include antiplatelet agents such as aspirin and anticoagulants like warfarin to prevent recurrent strokes. While regenerative therapies like Redasemtide, which promote tissue repair and regeneration, are still under investigation, there are no FDA-approved regenerative peptides specifically for stroke treatment as of now.

What other types of research exist?

Promising novel alternatives to Redasemtide for stroke patients include: 1) SAK-2RGD-TTI, a multifunctional staphylokinase variant with improved thrombolytic activity and prevention of reocclusion. 2) SC-49992, a mimetic peptide that enhances tissue plasminogen activator-induced thrombolysis and prevents reocclusion. 3) Thrombin-inhibiting nanoparticles, which have shown efficacy in delaying thrombotic occlusion with minimal systemic bleeding effects. These alternatives focus on different mechanisms such as thrombolysis, platelet aggregation inhibition, and targeted clot inhibition, offering potential benefits for stroke treatment.

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Redasemtide 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

Must not have

Use of prohibited concomitant medications or therapies listed in the protocol for the treatment of current AIS

Participants who have previously received redasemtide

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a medication called redasemtide to see if it can help adults who have had a stroke. The goal is to find out if this medication can protect brain cells and help them heal better after the stroke. Researchers are looking at both how well it works and if it is safe to use.

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.

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).

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not using any medications or therapies not allowed in the study for my AIS.

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I have previously received redasemtide.

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I have been diagnosed with a temporary stroke.

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My stroke mainly affected my cerebellum or brain stem.

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My blood pressure is still high despite taking medication for it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stroke, such as thrombolytics and neuroprotective agents, primarily aim to restore blood flow and protect brain tissue. Thrombolytics like tPA dissolve clots to re-establish blood flow, while neuroprotective agents help shield brain cells from further damage. Regenerative therapies, like Redasemtide, are designed to promote tissue repair and regeneration, which is vital for improving recovery and reducing long-term disability in stroke patients. These mechanisms are crucial as they not only address the immediate blockage but also enhance the brain's ability to heal and regain function.