Not recruiting

Study on the Safety and Effects 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. Afamelanotide is a type of hormone analogue, which means it mimics certain natural hormones in the body.

The purpose of this study is to evaluate the safety of afamelanotide in people who have been diagnosed with early Parkinson's Disease. Participants in the study will receive the treatment and be monitored for any side effects or changes in their condition. The study will also look at various markers in the blood and brain, such as levels of a protein called α-synuclein and inflammation indicators, to see how they change over time. Additionally, the study will assess changes in brain imaging and cognitive function.

The study will take place over a period of time, with participants receiving regular assessments to track their progress. The goal is to gather information on how afamelanotide affects individuals with early Parkinson's Disease and to determine its safety and potential benefits. Participants will not be required to take any other Parkinson's medications during 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
Enrollment
Eligibility is confirmed based on criteria such as a diagnosis of Parkinson's Disease (PD) within the last three years and age between 40 and 85 years.
No requirement for dopaminergic medication at the time of enrollment or expected need within three months.
Step 2
Baseline assessment
Initial assessments are conducted to establish baseline levels of various health indicators.
These include measurements of α-synuclein levels, inflammation biomarkers, and neuromelanin using MRI.
Step 3
Treatment administration
The medication afamelanotide is administered as a subcutaneous injection.
The product used is called PRENUMBRA, which is a solution for injection.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess any treatment-emergent adverse events.
Clinically significant changes in laboratory results are evaluated.
Step 5
Final assessment
Final assessments are conducted on Day 56, with a possible variation of two days.
Changes in α-synuclein levels, inflammation biomarkers, neuromelanin, cognition, and clinical improvement are measured from baseline to the final assessment.

Who can join the trial?

5 criteria

The patient must have been diagnosed with Parkinson's Disease less than three years before the first screening visit.
The patient should not yet need dopaminergic medication (medicines that help with movement problems) and should not be expected to need it within three months of joining the study.
The patient must be between 40 and 85 years old.
Both male and female patients can participate.
The study is not for vulnerable populations, meaning it is not designed for people who might need special protection or care.

Who cannot join the trial?

4 criteria

Individuals who do not have a diagnosis of Parkinson's Disease cannot participate. Parkinson's Disease is a condition that affects movement and can cause tremors and stiffness.
Participants must be within a specific age range, which is not specified here, but generally means they must be neither too young nor too old for the study.
Both males and females are eligible, so gender is not a reason for exclusion.
People who are considered part of a vulnerable population are not excluded. Vulnerable populations typically include groups like children, pregnant women, or those unable to give consent, but this study does not exclude them based on vulnerability.

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Verified sites

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Verified
Hospital Universitario Puerta De Hierro De Majadahonda
Majadahonda, Spain

Trial locations

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Investigated drugs

Afamelanotide is being studied to see if it is safe for people with early Parkinson's Disease. This medication is being tested to understand how it might help with the symptoms of Parkinson's Disease, which affects movement and coordination. The trial aims to find out if afamelanotide can be used safely in patients and if it has any positive effects on their condition.

Afamelanotide

What is already known about the treatment

Afamelanotide – Afamelanotide is administered as a subcutaneous implant, which means it is placed under the skin. It is currently being studied in clinical trials for its potential use in treating early Parkinson's Disease. The main therapeutic indication being explored is its ability to improve symptoms associated with this condition. At the molecular level, afamelanotide works by stimulating the production of melanin, which may have neuroprotective effects. It is classified pharmacologically as a melanocortin receptor agonist.

Investigated diseases

Parkinson's Disease – Parkinson's Disease is a progressive neurological disorder that primarily affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. The disease occurs when nerve cells in the brain that produce dopamine become impaired or die. As the condition progresses, symptoms may worsen, leading to increased difficulty in walking, talking, and completing simple tasks. Non-motor symptoms such as sleep disturbances, mood changes, and cognitive impairment can also occur. The progression of symptoms varies from person to person, and the rate of progression can differ significantly.