All studies
RecruitingPHASE3INTERVENTIONAL

Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke

This important study is investigating a new medication, sovateltide, for patients who have recently experienced an acute ischemic stroke. An ischemic stroke happens when a blood clot blocks blood flow to part of the brain. The study aims to confirm if sovateltide is safe and effective in helping people recover from this type of stroke. Researchers are looking for a therapy that can protect brain cells during a stroke and help with repair afterward. Previous studies have shown promising results with sovateltide in animal models and in human trials in India. This phase 3 study will compare sovateltide with a dummy treatment (normal saline) to evaluate its benefits, alongside standard medical care, for patients in the United States.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Pharmazz, Inc.
Enrolment target
514
Start
24 Jul 2025
Estimated completion
01 Nov 2026

What is this study about?

This study is looking into a new drug called sovateltide for people who have had a type of stroke called an acute ischemic stroke. A stroke happens when the blood supply to part of your brain is interrupted. An ischemic stroke, which is the most common kind, occurs when a blood clot blocks an artery, preventing blood and oxygen from reaching brain tissue. This can cause brain cells to be damaged or die.

Researchers are always searching for new treatments that can help protect the brain during a stroke and also help it recover afterward. So far, the main treatment for ischemic stroke involves medication to break up blood clots. This study is exploring a different approach with sovateltide. This drug has shown good results in animal studies and in earlier human trials in India, suggesting it might be a beneficial new option for stroke recovery.

This is a 'Phase 3' study, which means it's a large, important step in testing a new drug. The main goal is to carefully check if sovateltide is safe for people and if it can significantly improve recovery from an acute ischemic stroke. Participants in the study will also receive the usual care for stroke, so the study is looking at whether adding sovateltide makes an extra difference.

Key takeaways

  • This study tests a new drug called sovateltide for acute ischemic stroke.
  • It aims to see if sovateltide is safe and improves stroke recovery.
  • Earlier studies suggest sovateltide could be a promising new treatment.
  • Participants will receive either sovateltide or a dummy treatment, plus standard care.
  • You must have had an ischemic stroke within the last 24 hours to be considered.
  • Participation is voluntary, and you can leave the study at any time.

Who may be eligible?

To join this study, people must be between 18 and 80 years old. They must have had an ischemic stroke (a stroke caused by a blood clot) that is confirmed by a brain scan like a CT or MRI. The stroke symptoms must have started less than 24 hours before they get the first dose of the study drug.

There are also some criteria about how severe the stroke is, as measured by a specific scale used by doctors (NIHSS score between 8 and less than 20). Patients who are in a coma or have a very severe reduction in consciousness are not suitable for this study. People who have had a previous stroke and fully recovered before this new ischemic stroke might be eligible.

People cannot join if they are having certain other treatments for their stroke, such as surgery or special procedures that go inside blood vessels. Also, if a scan shows any bleeding in the brain (which is a different type of stroke), they cannot take part. The study team will review all medical information to see if someone is a good fit.

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.

  1. Are you between 18 and 80 years old?
  2. Have you had an ischemic stroke (caused by a blood clot), confirmed by a scan?
  3. Did your stroke symptoms start less than 24 hours ago?
  4. Are you NOT in a coma or needing strong stimulation to respond?
  5. Are you NOT having surgery or procedures that go inside blood vessels for your stroke?
Answer every question to see your result.

What does participation involve?

If you join this study, you would receive either the study drug, sovateltide, or a placebo (a dummy treatment, like normal saline, which looks the same but has no active drug). You will also receive the standard medical care for your stroke. The study team will give you specific appointments for the medication and follow-up care.

During your participation, doctors and nurses will closely monitor your health and recovery. This will likely involve regular medical examinations, brain scans, and assessments to measure your stroke recovery and how well you are doing. You would need to be available for these visits and follow-up checks for a set period to allow researchers to gather all the necessary information.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks to consider. A potential benefit of this study is that sovateltide might improve your recovery from the stroke more than standard care alone. However, since this is a research study, there's no guarantee it will help you personally. Potential risks could include side effects from the study drug, although sovateltide has been tested in earlier studies with a small number of people and found to be generally safe. You will be closely monitored for any reactions. It's very important to remember that participating is entirely your choice, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (42)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • The University of Arizona - College of Medicine
    Unverified
    Tuscon, United States· Recruiting
  • Mercy Medical Group
    Verified postcode
    Carmichael, United States· Recruiting
  • St. John's Regional Medical Center
    Verified postcode
    Oxnard, United States· Recruiting
  • SSM Health Neurosciences
    Verified postcode
    Bridgeton, United States· Recruiting
  • OSU Wexner Medical Center
    Verified postcode
    Columbus, United States· Recruiting
  • UPMC Presbyterian Hospital
    Verified postcode
    Pittsburgh, United States· Recruiting
  • CHI Memorial Neuroscience Institute
    Verified postcode
    Chattanooga, United States· Recruiting
  • Houston Medical Neurological Institute
    Verified postcode
    Houston, United States· Recruiting
  • Memorial Hermann Hospital
    Verified postcode
    Houston, United States· Recruiting
  • Klinikum Altenburger Land GmbH
    Verified postcode
    Altenburg, Germany· Recruiting
  • Universitaetsklinikum Goettingen
    Verified postcode
    Göttingen, Germany· Recruiting
  • Klinikum der Stadt Ludwigshafen gGmbh
    Verified postcode
    Rhein, Germany· Recruiting

Common questions

What is an acute ischemic stroke?

An acute ischemic stroke happens suddenly when a blood clot blocks an artery, stopping blood flow to part of your brain. This can damage brain cells.

What is sovateltide and how might it help?

Sovateltide is a new investigational drug being tested to see if it can protect brain cells during a stroke and help them repair afterward. Early studies have shown promising results.

Will I definitely get the actual drug if I join?

No, this is a 'blinded' study, meaning you might receive the active drug (sovateltide) or a placebo (normal saline). Neither you nor your doctors will know which one you are getting to keep the results fair.

How long does a stroke have to happen before I can join?

You must be able to receive the first dose of the study drug within 24 hours of your stroke symptoms starting.

Can I still have other stroke treatments if I join?

You will receive standard medical care for your stroke. However, if you're having certain other procedures like surgery or procedures that go through blood vessels for your stroke, you wouldn't be able to join this study.

How to find out more

Anil Gulati, MD, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Assess the Safety and Efficacy of Sovateltide in Patients Wi…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.