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Study on the Safety and Effectiveness of Sovateltide for Patients with Acute Ischemic Stroke

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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 treatment called Sovateltide in patients who have experienced an acute cerebral ischemic stroke. An acute cerebral ischemic stroke occurs when blood flow to a part of the brain is blocked, leading to potential damage. The study aims to determine if Sovateltide can help improve the recovery and functional outcomes of these patients.

Participants in the study will receive either Sovateltide or a matching placebo. Sovateltide is administered as an injection directly into the bloodstream. The study will follow participants for a period of 90 days after they are randomly assigned to receive either the treatment or the placebo. During this time, researchers will assess the participants' recovery and overall health.

The main goal of the study is to see if Sovateltide can lead to a good recovery, as measured by a scale that evaluates the level of disability or dependence in daily activities. The study will also look at other aspects of recovery, such as changes in quality of life and the occurrence of any additional strokes or health issues. Participants will be monitored closely to ensure their safety throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be randomly assigned to receive either the study medication, sovateltide, or a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.
The study is designed to be double-blind, meaning neither you nor the study team will know whether you are receiving sovateltide or the placebo.
Step 2
Initial treatment
You will receive the first dose of sovateltide or placebo within 24 hours of the onset of your stroke symptoms. This will be administered through an intravenous injection, which means the medication is given directly into a vein.
The timing of the first dose is crucial and is based on when your stroke symptoms began. If the stroke occurred during sleep, the time is considered from when you were last seen or reported to be normal.
Step 3
Treatment course
You will continue to receive the assigned treatment as per the study protocol. The exact dosage and frequency will be determined by the study team based on your specific condition and response to the treatment.
It is important to adhere to the treatment schedule and attend all follow-up visits as planned.
Step 4
Follow-up visits
You will have follow-up visits scheduled at various intervals to monitor your progress and assess the effects of the treatment.
These visits will include assessments using scales like the modified Rankin Scale (mRS) to evaluate your functional outcome, and other tests to measure your recovery and quality of life.
Step 5
Final assessment
The primary goal of the study is to determine if sovateltide leads to a good functional outcome, assessed by a modified Rankin Scale score of 0-2, 90 days after randomization.
Secondary assessments will include other measures of recovery and any potential side effects or adverse events experienced during the study period.

Who can join the trial?

6 criteria

Adults who are 18 to 80 years old.
Must give consent according to national laws and ethics committee requirements before any study procedures begin.
Must have a stroke that is ischemic (caused by a blockage in blood flow) and confirmed by a CT scan (a type of X-ray) or MRI (a scan that uses magnets and radio waves to create images of the body). There should be no bleeding in the brain as shown by these scans.
Must have had a stroke within 24 hours of the start of symptoms, with a NIHSS score (a measure of stroke severity) of 8 to less than 20, and a Level of Consciousness score of less than 2 at the time of screening. This includes patients who have fully recovered from previous strokes before having a new one, with a pre-stroke mRS score (a measure of disability) of 0-2.
The first dose of the study medication must be given within 24 hours from when the stroke symptoms began. If the stroke happened during sleep, the time of onset is when the person was last seen or reported to be normal.
Must be reasonably expected to complete the full course of the study medication or placebo and be available for follow-up visits.

Who cannot join the trial?

10 criteria

Patients who have had a **recent head injury** or **brain surgery**.
Patients with a **history of bleeding in the brain**.
Patients who have **uncontrolled high blood pressure**.
Patients with **severe liver or kidney disease**.
Patients who are **pregnant or breastfeeding**.
Patients who have had a **major surgery** in the last 30 days.
Patients with a **known allergy** to the study medication.
Patients who are currently participating in another clinical trial.
Patients with a **history of drug or alcohol abuse**.
Patients with **severe heart disease**.

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Verified sites

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Verified
Asklepios Kliniken Hamburg GmbH
Hamburg, Germany
Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain

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Investigated drugs

Sovateltide is a medication being studied to see if it can help people who have had a type of stroke called an acute cerebral ischemic stroke. This kind of stroke happens when blood flow to a part of the brain is blocked. The goal of using sovateltide in this study is to find out if it can improve the recovery of patients by helping them regain better function and independence. Researchers are looking at how well patients can perform daily activities and how much help they need after taking sovateltide, compared to those who do not take it. The study measures success by seeing if patients have a good outcome on a scale that assesses their ability to function normally 90 days after starting the treatment.

SOVATELTIDE

What is already known about the treatment

Sovateltide – Sovateltide is administered as an injection, typically given in a hospital setting. It is currently being studied in clinical trials to evaluate its safety and effectiveness for treating acute cerebral ischemic stroke, a condition where blood flow to the brain is blocked. The main goal of using sovateltide is to improve the patient's recovery and functional outcome after a stroke. At the molecular level, sovateltide works by targeting specific receptors in the brain that may help protect nerve cells and improve blood flow. It is classified as a neuroprotective agent, which means it helps protect the brain from damage.

Investigated diseases

Acute cerebral ischemic stroke – This condition occurs when blood flow to a part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. The lack of blood flow 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, or difficulty understanding speech. As the condition progresses, it can lead to problems with movement, speech, and memory. The severity of these symptoms can vary depending on the size and location of the stroke. Recovery and improvement of function can occur over time, but the extent varies among individuals.