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Safety Study of Afamelanotide for Patients with Early Parkinson's Disease

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 Parkinson's Disease, a condition that affects movement and can cause symptoms like tremors, stiffness, and difficulty with balance and coordination. The trial will use a treatment called afamelanotide, which is administered as a solution for injection under the skin. The purpose of the study is to evaluate the safety of afamelanotide in patients who have been diagnosed with early Parkinson's Disease.

Participants in the study will receive the treatment and be monitored over a period of time to assess any side effects or changes in their condition. The study will look at various factors, including changes in certain proteins and inflammation markers in the blood, as well as any improvements in cognitive function and brain imaging results. These assessments will help researchers understand how the treatment affects the body and its potential benefits for people with early Parkinson's Disease.

The study is designed to gather important information about the safety of afamelanotide and its effects on patients with early Parkinson's Disease. By participating in this trial, researchers hope to gain insights that could lead to better treatment options for this condition in the future.

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
Enrollment
Upon joining the study, you will be confirmed as eligible based on specific criteria. You must have been diagnosed with Parkinson's Disease less than three years ago and be between 40 and 85 years old. You should not yet require dopaminergic medication nor be expected to need it within three months of enrollment.
Step 2
Initial assessment
You will undergo an initial assessment to establish baseline measurements. This includes blood tests to measure levels of certain proteins and inflammation markers, as well as cognitive tests and an MRI scan to assess brain changes.
Step 3
Treatment administration
You will receive the medication afamelanotide through a subcutaneous injection. This means the medication is injected under the skin. The exact dosage and frequency will be explained to you by the medical team.
Step 4
Monitoring and follow-up
Throughout the study, you will be monitored for any side effects or changes in your health. This includes regular check-ups and tests to track any changes in your condition or in the levels of specific markers in your blood.
Step 5
Final assessment
At the end of the study period, which lasts until approximately April 2024, you will undergo a final assessment. This will include the same tests as the initial assessment to evaluate any changes in your condition and to ensure your safety.

Who can join the trial?

4 criteria

Patient has been diagnosed with Parkinson's Disease less than three years ago.
Patient does not need medication that increases dopamine levels, and it is not expected that they will need it within three months of joining the study. Dopamine is a chemical in the brain that helps control movement.
Patient is between 40 and 85 years old.
Both male and female patients can participate.

Who cannot join the trial?

3 criteria

Patients who do not have Parkinson's Disease cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

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Verified
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy

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Investigated drugs

Afamelanotide is a medication being studied for its safety in patients with early Parkinson's Disease. It is designed to help protect and repair cells in the body. In this trial, researchers are looking to see if it is safe for people with early stages of Parkinson's Disease to use. The goal is to understand if it can be a helpful treatment option for managing the symptoms or progression of the disease. Participants in the trial will receive this medication to see how their bodies respond to it and to monitor any side effects that may occur.

Afamelanotide

What is already known about the treatment

Afamelanotide – Afamelanotide is administered as an implant placed under the skin, where it slowly releases the medication into the body. It is currently being studied in clinical trials for its safety in treating early Parkinson's Disease, a condition that affects movement and coordination. The main therapeutic indication for afamelanotide in this trial is to assess its safety profile in patients with early stages of Parkinson's Disease. At the molecular level, afamelanotide works by mimicking a natural hormone in the body that can influence various biological processes, although its exact mechanism in Parkinson's Disease is still under investigation. It is classified pharmacologically as a synthetic analog of a naturally occurring hormone.

Investigated diseases

Parkinson's Disease – Parkinson's Disease is a progressive neurological disorder that affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. The disease progresses gradually, often starting with barely noticeable tremors in one hand. As it advances, individuals may experience slower movement, muscle rigidity, and impaired posture. Over time, Parkinson's Disease can also lead to changes in speech and writing. The progression of symptoms varies from person to person, and the rate of progression can differ significantly.