RecruitingPHASE2INTERVENTIONAL

A Study of TAK-755 in Adults With Acute Ischemic Stroke

This research study is looking at a new medicine called TAK-755 for adults who have recently had a specific type of stroke called an acute ischemic stroke. This type of stroke happens when a blood clot blocks blood flow to part of the brain. The main goals of the study are to check if TAK-755 is safe, if people can take it without too many side effects, and if it helps improve their daily activities and stroke symptoms compared to a placebo (a dummy medicine with no active drug). Everyone taking part will get either TAK-755 or the placebo, in addition to their usual hospital stroke care. Their health will be checked for about three months after they receive the treatment.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Takeda

Enrolment target

222

Start

17 May 2026

Estimated completion

06 Dec 2027

Acute Ischemic Stroke

What is this study about?

When someone has an acute ischemic stroke, it means a blood clot has suddenly blocked the flow of blood to a part of their brain. This can cause serious problems, and it's vital to try and restore blood flow quickly to limit damage. Researchers are always looking for new ways to help people recover from strokes and reduce their impact on daily life.

This study is testing a new experimental medicine called TAK-755. The main purpose is to learn more about TAK-755, specifically how safe it is for people who have just had a stroke, and whether they can tolerate it well. Researchers will also be looking to see if TAK-755 might help people manage their daily activities better and if it helps reduce the severity of their stroke symptoms, compared to a placebo.

A placebo looks exactly like the real medicine but doesn't contain any active drug. This helps the researchers fairly compare the effects of TAK-755 against simply receiving standard care, without anyone knowing whether they're getting the active drug or not. All participants in this study will also receive the standard care for stroke that their hospital normally provides, whether they get TAK-755 or the placebo.

Key takeaways

This study is for adults who have recently had a specific type of stroke (acute ischemic stroke).
It's testing a new medicine called TAK-755 to see if it's safe, tolerable, and helps with recovery.
Participants will receive either TAK-755 or a placebo, plus their usual hospital stroke care.
Your health will be monitored for about 3 months after receiving the study treatment.
Participation is voluntary, and you can stop at any time.

Who may be eligible?

To be part of this study, you would generally need to be an adult, aged 18 or older, who has recently had an acute ischemic stroke. The stroke symptoms would need to have started within 24 hours of when you might join the study. Your stroke would also need to be considered moderate to severe, affecting certain areas of the brain, and doctors would need to see that there's still brain tissue that could potentially be saved by treatment.

There are also some reasons why someone might not be able to join. For example, if you weigh more than 130 kg or less than 40 kg, or if you've had a serious head injury, bleeding in the brain, or a brain tumour recently. The study team will review all your medical information carefully to see if this study is right for you.

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 18 years old or older?
Have you recently had a sudden stroke (acute ischemic stroke)?
Did your stroke symptoms start within the last 24 hours?
Do you currently have moderate to severe stroke symptoms?
Do you have a general understanding of English to follow study information?

Answer every question to see your result.

What does participation involve?

If you join the study, you will receive either the study medicine (TAK-755) or a placebo (a dummy medicine) once, through a drip. You will not know which one you are receiving. This will happen in addition to the standard stroke care you would normally receive at the hospital. After this, the study team will monitor your health closely for about three months (90 days). This will involve several visits or check-ups, where they might ask you questions about how you're feeling, perform some physical examinations, and possibly do other tests to see how you are recovering and how the treatment is affecting you.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. You might benefit from closer medical attention and potentially from TAK-755 if it proves to be effective. However, there's no guarantee that you will personally benefit. TAK-755 is an experimental medicine, so there might be side effects or risks that are not yet fully known. The study team will explain these to you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (60)

HonorHealth Neurology
Verified postcode
Scottsdale, United States· Recruiting
University of Arizona
Verified postcode
Tucson, United States· Not yet recruiting
University of California San Francisco
Verified postcode
San Francisco, United States· Not yet recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Not yet recruiting
University at Buffalo
Verified postcode
Buffalo, United States· Not yet recruiting
University of Pittsburgh Medical Center
Verified postcode
Pittsburgh, United States· Not yet recruiting
Vanderbilt University Medical Center
Verified postcode
Nashville, United States· Not yet recruiting
HCA Houston Healthcare - North Cypress
Verified postcode
Cypress, United States· Not yet recruiting
Neurology Consultants of Dallas, PA
Verified postcode
Dallas, United States· Not yet recruiting
Ziekenhuis Oost-Limburg
Verified postcode
Genk, Belgium· Not yet recruiting
Universitair Ziekenhuis Gent (Belgium,Ghent)
Verified postcode
Ghent, Belgium· Not yet recruiting
AZ Groeninge
Verified postcode
Kortrijk, Belgium· Not yet recruiting

Common questions

What is an acute ischemic stroke?

It's a type of stroke caused by a blood clot blocking blood flow to part of the brain, suddenly stopping oxygen and nutrients from getting through.

What is TAK-755?

TAK-755 is a new medicine being tested in this study. It's not yet approved for general use, and researchers want to find out if it's safe and effective for stroke patients.

What is a placebo?

A placebo looks just like the study medicine but contains no active drug. It helps researchers compare the effects of the real medicine accurately.

Will I still get my usual stroke treatment?

Yes, everyone in the study will receive the standard stroke care that the hospital normally provides, in addition to either TAK-755 or the placebo.

How long will I be in the study?

You'll receive the study treatment once, and your health will then be monitored for about three months (90 days).

How to find out more

Takeda Contact

medinfous@takeda.com +1-877-825-3327 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.