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Study on the Effects of Lenomorelin in Patients with Acute Ischemic Stroke Undergoing Endovascular Thrombectomy

Verified siteInvestigationalNo placebo

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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 for patients who have experienced an ischemic stroke. An ischemic stroke occurs when a blood clot blocks a blood vessel in the brain, leading to a reduction in blood flow and oxygen to the brain. This study will use a treatment called Acyl-ghreline, also known by its code name G-3370-R. Acyl-ghreline is a form of a hormone that is being tested to see if it can help reduce the severity of the stroke's impact on the brain.

The purpose of this study is to assess how Acyl-ghreline affects the severity of neurological symptoms in patients who have had an acute ischemic stroke. These patients will have already received a procedure called endovascular thrombectomy, which is a treatment to remove the blood clot from the brain's blood vessels. The study will involve administering Acyl-ghreline through an injection and observing its effects over a period of time.

Participants in the study will be monitored for changes in their condition at various intervals, including seven days after the stroke and again at 90 days. The study will look at different aspects of recovery, such as the ability to perform daily activities and overall health status. The goal is to determine if Acyl-ghreline can improve recovery outcomes for stroke patients. The study is expected to continue until 2026, with recruitment starting in 2024.

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 required to provide written informed consent. This consent may be deferred, meaning it can be obtained after the initial emergency treatment if necessary.
You must have a clinical diagnosis of an acute ischemic stroke, which is a type of stroke caused by a blockage in a large blood vessel in the brain. This will be confirmed through imaging tests like a CT or MRI scan.
Step 2
Initial treatment
You will receive treatment with endovascular thrombectomy (EVT), a procedure that involves removing the blood clot causing the stroke. This is done through a small puncture in the groin area.
Before the EVT, a score of at least 10 on the National Institutes of Health Stroke Scale (NIHSS) is required. This scale measures the severity of your stroke symptoms.
Step 3
Administration of study medication
Within 6 hours of the stroke onset, you will begin receiving the study medication, Acyl-ghreline, which contains the active substance lenomorelin.
The medication is administered as an intravenous bolus injection or infusion, which means it is given directly into your bloodstream through a vein.
Step 4
Monitoring and assessments
Your neurological condition will be assessed using the NIHSS at 24 hours, 72 hours, and 7 days after the stroke onset. This helps to evaluate the effect of the medication on your stroke symptoms.
Additional assessments will include monitoring your blood glucose levels, blood pressure, and body temperature daily for up to 7 days or until discharge from the hospital.
Step 5
Follow-up evaluations
At 90 days after the stroke, you will have follow-up evaluations to assess your recovery. This includes the modified Rankin Scale (mRS) to measure your level of disability, the Barthel Index to evaluate your ability to perform daily activities, and a telephone version of the Montreal Cognitive Assessment (t-MoCA) to check your cognitive function.
Your mortality status and any serious adverse events (SAEs) will also be recorded at this time.

Who can join the trial?

7 criteria

Have a clinical diagnosis of acute ischemic stroke, which is a type of stroke caused by a blockage in a large blood vessel in the brain's front part. This must be confirmed by a brain scan like a CT (Computed Tomography) or MRI (Magnetic Resonance Imaging).
Have been treated with EVT (Endovascular Therapy), which involves a procedure starting with a groin puncture to remove the blockage.
A brain scan (CT or MRI) must show no bleeding in the brain.
Have a score of at least 10 on the NIHSS (National Institutes of Health Stroke Scale), which is a measure of stroke severity, before receiving EVT.
Be 18 years of age or older.
Provide written informed consent, which may be given after the treatment has started.
Be able to start the trial treatment within 6 hours of the stroke beginning.

Who cannot join the trial?

5 criteria

Patients who have had a **stroke** caused by a blockage in a large blood vessel in the front part of the brain.
Patients who are not treated with **EVT** (a procedure to remove the blockage in the blood vessel).
Patients who are not within seven days of the start of their stroke symptoms.
Patients who are not in the age range specified for the study.
Patients who are part of a vulnerable population that the study does not include.

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Verified sites

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Verified
Isala Klinieken Stichting
Zwolle, The Netherlands
Verified
Rijnstate Ziekenhuis Stichting
Arnhem, The Netherlands
Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

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Investigated drugs

Ghrelin is a hormone that is naturally produced in the body, mainly in the stomach. It is often called the "hunger hormone" because it stimulates appetite. In this clinical trial, ghrelin is being studied to see if it can help improve recovery in patients who have had a type of stroke called an ischemic stroke. This type of stroke happens when a blood clot blocks a blood vessel in the brain. The trial is looking at whether ghrelin can reduce the severity of the stroke's effects on the brain when given to patients who are also receiving a treatment called endovascular thrombectomy, which is a procedure to remove the clot from the blood vessel.

Lenomorelin

What is already known about the treatment

Ghrelin – Ghrelin is administered as an injection and is currently being studied in clinical trials for its potential benefits in treating stroke. It is not yet widely used in standard medical practice, but research is ongoing to understand its effects better. The main therapeutic indication being explored is its ability to reduce neurological deficits in patients who have suffered an acute ischemic stroke, particularly those treated with endovascular thrombectomy. At the molecular level, ghrelin works by binding to specific receptors in the brain, which may help protect nerve cells and improve recovery after a stroke. It is classified as a peptide hormone with potential neuroprotective properties.

Investigated diseases

Stroke – Stroke is a medical condition that occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can happen due to a blocked artery (ischemic stroke) or the leaking or bursting of a blood vessel (hemorrhagic stroke). In ischemic stroke, the most common type, a blood clot or other debris blocks the blood flow to the brain. As a result, brain cells begin to die within minutes. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty understanding speech. The progression of a stroke can lead to significant neurological deficits, depending on the area of the brain affected and the duration of the interruption in blood flow.