Not recruiting

Study on the Safety of Afamelanotide for Patients with Acute Arterial Ischemic Stroke Ineligible for Standard Stroke Treatments

InvestigationalNo 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 safety of a treatment for patients who have experienced an acute Arterial Ischaemic Stroke (AIS). This type of stroke occurs when blood flow to a part of the brain is blocked, leading to potential damage. The treatment being tested is called afamelanotide, which is administered as a solution for injection. The purpose of the study is to evaluate how safe this treatment is for patients who are not eligible for other common stroke treatments like intravenous thrombolysis or endovascular thrombectomy.

During the study, participants will receive the afamelanotide injection and will be monitored to see how their bodies respond to the treatment. The study will include patients with varying levels of stroke severity, from mild to severe. Researchers will keep track of any side effects that may occur and will also assess changes in the patients' condition using several measures, such as the NIHSS score, which helps determine the severity of a stroke, and the mRS score, which evaluates the level of disability. Additionally, the study will look at the volume of brain tissue that can be saved after the stroke and how well patients can perform daily activities compared to before the stroke.

The study aims to provide valuable information about the safety of afamelanotide in treating acute Arterial Ischaemic Stroke, potentially offering a new option for patients who cannot undergo other treatments. The trial is expected to continue until early 2025, with the recruitment of participants having started in early 2023.

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 means you agree to participate after understanding the study details.
You will be assessed to confirm your eligibility. This includes checking your age, stroke severity, and other health criteria.
Step 2
Initial assessment
A healthcare professional will evaluate your condition using the NIHSS score, which measures the severity of your stroke.
A CTP scan may be performed to observe any blood flow abnormalities in your brain.
Step 3
Treatment administration
You will receive a medication called afamelanotide in the form of a solution for injection. This is administered to evaluate its safety in treating your condition.
The dosage and frequency of the injection will be determined by the study protocol and administered by a healthcare professional.
Step 4
Monitoring and follow-up
Throughout the study, your health will be closely monitored for any treatment-emergent adverse events (TEAEs).
Your NIHSS score will be regularly checked to assess any changes in your condition.
Additional assessments may include evaluating your ability to perform daily activities and cognitive function using the mRS and MMSE scores.
Step 5
Completion of the study
At the end of the study, a final assessment will be conducted to evaluate your overall health and any changes since the beginning of the trial.
You will receive information about the study results and any further steps if necessary.

Who can join the trial?

6 criteria

Men or women who have had their first **Arterial Ischaemic Stroke (AIS)**, which is a type of stroke caused by a blockage in the arteries.
Participants will include six people with mild to moderate stroke severity and six people with moderate to severe stroke severity.
At least three participants should have a **NIHSS score** (a scale used to measure the severity of a stroke) between 1 and 15, and at least three participants should have a score greater than 15. Some participants should show blood flow issues on a **Computed Tomography Perfusion (CTP)** scan, while others may not show these issues but are still suspected to have AIS.
Participants should have a **pre-stroke mRS** (a scale that measures the degree of disability or dependence in daily activities) of less than 4.
Participants must be between 18 and 85 years old.
Written informed consent must be obtained from the participant or their medical decision-maker before the study begins.

Who cannot join the trial?

4 criteria

Patients who have had a recent **Arterial Ischaemic Stroke (AIS)** cannot participate. This is a type of stroke caused by a blockage in the arteries that supply blood to the brain.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of people.
Patients who are considered part of a **vulnerable population** cannot participate. This term refers to groups of people who may be at a higher risk of harm or exploitation.

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Investigated drugs

Afamelanotide is a medication being studied for its safety in patients who have had an acute arterial ischemic stroke. This type of stroke happens when a blood clot blocks an artery in the brain, reducing blood flow and oxygen. Afamelanotide is being tested in patients who cannot receive other common stroke treatments like clot-busting drugs or surgery to remove the clot. The goal of using afamelanotide in this study is to see if it is safe for these patients and to understand how it might help in their recovery.

Afamelanotide

What is already known about the treatment

Afamelanotide – Afamelanotide is administered as an aqueous solution, typically through injection. It is currently being studied in clinical trials for its safety in treating patients with acute Arterial Ischaemic Stroke (AIS) who cannot undergo standard treatments like Intravenous Thrombolysis (IVT) or Endovascular Thrombectomy (EVT). The main therapeutic indication for afamelanotide in this context is to address AIS. At the molecular level, afamelanotide works by mimicking a natural hormone in the body that can help protect cells and tissues from damage. It is classified pharmacologically as a synthetic peptide.

Investigated diseases

Arterial Ischaemic Stroke (AIS) – Arterial Ischaemic Stroke occurs when a blood clot blocks an artery supplying blood to the brain, leading to a reduction in blood flow and oxygen to brain tissue. This blockage can cause brain cells to begin dying within minutes. The progression of the disease involves the initial formation of the clot, followed by the development of an ischaemic core where brain cells are irreversibly damaged. Surrounding this core is the penumbral zone, where cells are at risk but potentially salvageable if blood flow is restored. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, or difficulty seeing. The extent of the damage and symptoms can vary depending on the location and size of the blockage.