Active not recruitingPHASE2INTERVENTIONAL

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

This research study is testing a new medication called Redasemtide for adults who have recently experienced a stroke, specifically a type called an acute ischaemic stroke. The main goals are to find out if this new medicine is safe to use and if it can help people recover from their stroke. The study will include two groups of patients: one group who can't have or don't need regular stroke treatments, and another group who can have or have already had these regular treatments. Participants will either receive Redasemtide or a dummy medicine (placebo). This is a 'Phase 2b' study, meaning it's an early but important step in checking if the medicine works and is safe before more people might use it in the future.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Shionogi

Enrolment target

680

Start

14 Jul 2023

Estimated completion

30 Jun 2026

Acute Ischemic Stroke

What is this study about?

This study is all about a new medicine called Redasemtide, which is being tested for people who have recently had a stroke. A stroke happens when the blood supply to part of your brain is cut off, often because of a clot. This type of stroke is called an acute ischaemic stroke. The researchers want to find out two main things: first, if Redasemtide is safe for people to take, and second, if it can help improve their recovery after a stroke.

The study will involve adults and is split into two main groups. One group will include people who, for various reasons, can't receive or haven't already received the usual treatments for stroke, such as clot-busting medicines or procedures to remove clots. The other group will include people who can receive or have already received these standard stroke treatments. This helps the researchers understand how Redasemtide might work in different situations and alongside other care.

In both groups, participants will either be given the new medicine, Redasemtide, or a placebo. A placebo looks exactly like the real medicine but doesn't contain any active ingredients. This is a common way to test new medicines and helps researchers fairly compare how well the new medicine works. By doing this, the doctors can see if any improvements are genuinely due to Redasemtide or if they might happen naturally.

Key takeaways

This study is testing a new medicine (Redasemtide) for recent strokes.
It aims to check if the medicine is safe and if it helps people recover.
Participants will receive either the new medicine or a dummy pill (placebo).
It includes people who can and can't receive standard stroke treatments.
You can take part if your stroke happened within 25 hours.
Your health will be closely monitored throughout the study.

Who may be eligible?

To join this study, you would need to be an adult, and your stroke must have happened fairly recently – within 25 hours before you start the study medicine. Doctors will also check your current health to make sure you are stable enough to take part.

There are two main groups in the study. In one group, you would be included if your doctor decides that the usual clot-busting treatments or clot-removing procedures aren't suitable for your current stroke. In the other group, you would be included if your doctor decides you are suitable for, or have already received, those standard stroke treatments.

Some things might mean you can't join. For example, if you have other serious health conditions or a neurological problem that the doctors think would get in the way of the study. Also, if your level of consciousness is very low due to the stroke, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult (18 years or older)?
Did your stroke happen within the last 25 hours?
Are you generally stable, apart from your stroke?
Have you discussed with your doctor whether you are suitable for standard stroke treatments?
Are you able to attend all necessary appointments for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a check-up to see if you're suitable. Once enrolled, you would receive either the new study medicine, Redasemtide, or a placebo (a dummy medicine). Neither you nor your study doctor would know which one you are receiving – this is called a 'double-blind' study and helps keep the results fair.

You would have several visits to the clinic or hospital for assessments. These will involve doctors checking your health and recovery, possibly through physical examinations, questionnaires, and other tests. The doctors will monitor you closely to see how you are responding to the treatment and if you experience any side effects.

Your participation would involve a initial treatment period, followed by regular check-ups to track your progress. The total length of your involvement in the study, including all follow-up appointments, would be explained to you in detail by the study team.

Potential risks and benefits

Taking part in any medical study has possible benefits and risks. You might not directly benefit from taking the study medicine, but your involvement could help doctors learn more about stroke and potentially help others in the future. As Redasemtide is a new medicine, there might be side effects that are not yet fully known. The study team will monitor you very closely for any changes in your health or any problems. You will be given full information about all known potential risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (150)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Banner University of Arizona Medical Center
Verified postcode
Tucson, United States
Intercoastal Medical Group
Verified postcode
Sarasota, United States
Augusta University
Verified postcode
Augusta, United States
Mercyhealth Javon Bea Hospital- Riverside
Verified postcode
Rockford, United States
Community Hospital
Verified postcode
Munster, United States
Sinai Hospital of Baltimore
Verified postcode
Baltimore, United States
Munson Healthcare
Verified postcode
Traverse City, United States
Mayo Clinic Hospital-Rochester, St. Mary's Campus - PPDS
Verified postcode
Rochester, United States
North Shore University Hospital-300 Community Dr
Verified postcode
Manhasset, United States
Nuvance Health Medical Practice, PC- Neurosurgery
Verified postcode
Poughkeepsie, United States
Summa Health System - Akron Campus
Verified postcode
Akron, United States
Ohio State University Wexner Medical Center
Verified postcode
Columbus, United States

Common questions

What is an acute ischaemic stroke?

It's the most common type of stroke, caused by a blood clot blocking blood flow to part of the brain.

What does 'Redasemtide or Placebo' mean?

You'll either get the new study medicine (Redasemtide) or a dummy medicine that looks the same but has no active drug (Placebo).

Why are there two different groups of patients?

This helps researchers see how the new medicine works both with and without the usual stroke treatments, covering different patient situations.

Is the study medicine available to everyone after the study?

No, this is a research study. New medicines usually need more testing and approval before they can be widely available.

What happens if I change my mind about volunteering?

You can leave the study at any time without giving a reason, and it won't affect your regular medical care.