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
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.
- Are you between 18 and 80 years old?
- Have you had an ischemic stroke (caused by a blood clot), confirmed by a scan?
- Did your stroke symptoms start less than 24 hours ago?
- Are you NOT in a coma or needing strong stimulation to respond?
- Are you NOT having surgery or procedures that go inside blood vessels for your stroke?
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
Locations (42)
- The University of Arizona - College of MedicineUnverifiedTuscon, United States· Recruiting
- Mercy Medical GroupVerified postcodeCarmichael, United States· Recruiting
- St. John's Regional Medical CenterVerified postcodeOxnard, United States· Recruiting
- SSM Health NeurosciencesVerified postcodeBridgeton, United States· Recruiting
- OSU Wexner Medical CenterVerified postcodeColumbus, United States· Recruiting
- UPMC Presbyterian HospitalVerified postcodePittsburgh, United States· Recruiting
- CHI Memorial Neuroscience InstituteVerified postcodeChattanooga, United States· Recruiting
- Houston Medical Neurological InstituteVerified postcodeHouston, United States· Recruiting
- Memorial Hermann HospitalVerified postcodeHouston, United States· Recruiting
- Klinikum Altenburger Land GmbHVerified postcodeAltenburg, Germany· Recruiting
- Universitaetsklinikum GoettingenVerified postcodeGöttingen, Germany· Recruiting
- Klinikum der Stadt Ludwigshafen gGmbhVerified postcodeRhein, 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?
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