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Study on Redasemtide for Adults with Acute Ischemic Stroke Not Eligible for Standard Treatments

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for acute ischemic stroke, a condition where blood flow to a part of the brain is blocked, leading to potential brain damage. The treatment being tested is called redasemtide (also known by its code name S-005151), which is administered as a lyophilized powder through an intravenous infusion. The study will compare the effects of redasemtide with a placebo in adult participants who have experienced an acute ischemic stroke and are not eligible for certain standard treatments like tissue plasminogen activator or thrombectomy.

The purpose of the study is to evaluate how effective and safe redasemtide is compared to a placebo. Participants in the study will receive either the redasemtide treatment or a placebo, and their progress will be monitored over a period of time. The study will involve regular check-ups and assessments to track the participants' recovery and any changes in their condition. The main goal is to see if redasemtide can improve outcomes for people who have had an acute ischemic stroke.

Throughout the study, participants will be evaluated using various measures, including the mRS score, which assesses the degree of disability or dependence in daily activities, and the NIHSS score, which measures the severity of stroke symptoms. These assessments will help determine the effectiveness of the treatment. The study aims to provide valuable information on whether redasemtide can be a beneficial treatment option for those affected by acute ischemic stroke.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be randomly assigned to receive either the study medication, redasemtide (S-005151), or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

  2. Step 2

    Treatment administration

    The treatment involves receiving the assigned medication through an intravenous infusion. This means the medication is given directly into a vein using a needle. The infusion will be administered within 25 hours of the onset of the stroke symptoms.

  3. Step 3

    Monitoring and follow-up

    Participants will be monitored regularly to assess their health and the effects of the treatment. This includes checking vital signs such as blood pressure, body temperature, respiratory rate, and pulse rate.

    Participants will also undergo various assessments to evaluate their recovery progress. These assessments include the modified Rankin Scale (mRS) and the National Institutes of Health Stroke Scale (NIHSS), which measure the level of disability and neurological function, respectively.

    Additional evaluations will be conducted at specific intervals, including at Day 30, Day 90, and Day 180, to track changes in health status and recovery.

  4. Step 4

    Completion of the study

    The study is expected to conclude by December 31, 2024. Participants will have completed all necessary follow-up visits and assessments by this time.

Who can join the trial?

9 criteria

  • Must be a male or female adult who is 18 years or older.
  • Must be able to give informed consent, which means agreeing to participate after understanding the study details. If unable to consent, a legal representative can do so on their behalf.
  • Must have a diagnosis of ischemic stroke in a specific brain area, confirmed by a CT or MRI scan. These scans are special images of the brain.
  • Must be able to start the study treatment within 25 hours of stroke onset. If the exact time is unknown, the last time the person was known to be well is used.
  • Must not be eligible for certain stroke treatments like thrombolysis or endovascular therapy, which are procedures to restore blood flow.
  • Must have a NIHSS score between 8 and 22. This score measures the severity of the stroke.
  • Must be medically stable at the time of joining the study, meaning no major changes in health are expected soon.
  • Must weigh between 30 kg and 150 kg.
  • If female, must not be pregnant or breastfeeding. If able to have children, must use a reliable method of birth control and have a negative pregnancy test before starting the study.

Who cannot join the trial?

10 criteria

  • Patients who have had a **recent heart attack** cannot participate. A heart attack is when blood flow to the heart is blocked.
  • Patients with **severe liver disease** are excluded. This means the liver is not working properly.
  • Patients with **severe kidney disease** cannot join. This means the kidneys are not functioning well.
  • Patients who are **pregnant or breastfeeding** are not allowed to participate.
  • Patients with **uncontrolled high blood pressure** are excluded. This means blood pressure is too high and not managed by medication.
  • Patients with a **history of bleeding disorders** cannot participate. This means they have problems with blood clotting.
  • Patients who have had a **major surgery** in the last 3 months are not eligible. Major surgery is a significant operation that requires a hospital stay.
  • Patients with **active cancer** are excluded. This means cancer that is currently being treated or is spreading.
  • Patients with **severe mental health conditions** cannot join. This includes conditions that affect thinking, feeling, or behavior.
  • Patients who are **currently participating in another clinical trial** are not allowed to join this study.
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Investigated drugs

Redasemtide (S-005151) is a medication being studied for its potential to help people who have had an acute ischemic stroke. This type of stroke happens when a blood clot blocks a blood vessel in the brain, reducing blood flow and causing brain cells to die. Redasemtide is being tested to see if it can improve recovery by helping to repair and protect brain cells after a stroke. The trial is focused on patients who cannot receive other common stroke treatments like clot-busting drugs or surgical procedures to remove the clot. The goal is to see if redasemtide can help these patients recover better than if they received no active treatment at all.

What is already known about the treatment

Redasemtide – Redasemtide is administered to patients in a clinical trial setting, typically through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. It is currently being studied in a phase 2b clinical trial to assess its effectiveness and safety for treating acute ischemic stroke in adults who cannot receive standard treatments like tissue plasminogen activator or thrombectomy. The main therapeutic indication for redasemtide is to help improve outcomes in patients who have suffered an acute ischemic stroke. At the molecular level, redasemtide is believed to work by promoting the repair and regeneration of damaged tissues, although the exact mechanism is still under investigation. It is classified pharmacologically as a regenerative medicine, focusing on aiding the body's natural healing processes.

Investigated diseases

Acute Ischemic Stroke – Acute ischemic stroke occurs when a blood clot blocks or narrows an artery leading to the brain, resulting in reduced blood flow and oxygen to brain tissue. This blockage can cause brain cells to begin dying within minutes. Symptoms often include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, vision problems, dizziness, and loss of balance or coordination. The progression of the disease can lead to significant neurological damage if blood flow is not quickly restored. The severity and specific symptoms depend on the location and extent of the blockage. Recovery and progression vary widely among individuals, influenced by the size and location of the stroke and the speed of medical intervention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501890-38-00Protocol code2138P2231Estimated enrolment430 patientsSponsorShionogi B.V.

sourced from the EU Clinical Trials Register and site verification

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