RecruitingPHASE1INTERVENTIONAL

A Phase I Study in Healthy Volunteers and Parkinson's Disease (PD) Patients.

This research is an early-stage clinical trial (Phase 1) that aims to find out if a new medication, MTX325, could be a future 'disease-modifying' treatment for Parkinson's disease. This means it's hoped that MTX325 might be able to slow down or even stop the progression of the disease, rather than just helping with symptoms. The study includes both healthy volunteers and people who have mild to moderate Parkinson's disease. Researchers want to understand how MTX325 works in the body, if it's safe, and what doses are appropriate. Participants will receive either MTX325 or a placebo (a dummy treatment). This is an important step in developing new treatments for Parkinson's.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Mission Therapeutics

Enrolment target

106

Start

30 Nov 2023

Estimated completion

27 Dec 2027

Parkinson's Disease (PD)Mild to Moderate Parkinson's Disease Early Stage Parkinson's Disease

What is this study about?

Parkinson's disease is a condition that affects the brain and can cause problems with movement, balance, and other body functions. Current treatments mainly help manage the symptoms. This study is exciting because it's looking into a new medication called MTX325, which researchers hope might actually change how Parkinson's disease develops, rather than just helping with the existing symptoms. This is known as a 'disease-modifying' treatment.

This is a 'Phase 1' study, which is the very first step in testing a new drug in humans. The main goals at this stage are to understand if MTX325 is safe for people, how much of it the body can handle, and how it moves through and leaves the body. It also helps researchers decide on the best dose for future studies. They're testing it in both healthy volunteers and people with Parkinson's disease to get a full picture.

By taking part, volunteers are helping scientists learn more about MTX325. The aim is to gather enough information to decide if this medication should be tested further in larger studies, moving closer to potentially offering a new, groundbreaking treatment option for people living with Parkinson's disease.

Key takeaways

This is an early-stage study (Phase 1) for Parkinson's disease.
It's testing a new drug, MTX325, that could potentially slow down Parkinson's.
The study includes both healthy volunteers and people with Parkinson's.
The main goals are to check the drug's safety and how it works in the body.
Participants will receive either MTX325 or a placebo.
Your involvement could help develop future Parkinson's treatments.

Who may be eligible?

This study is looking for both healthy volunteers and people with Parkinson's disease. If you're generally healthy, you need to be between 18 and 55 years old. If you have Parkinson's disease, you can be between 18 and 75 years old, and your Parkinson's should be mild to moderate.

There are also some general health requirements. For example, you need to be a certain weight, with a healthy Body Mass Index (BMI). You shouldn't have any serious allergies to the medication being tested or its ingredients. They'll also check your blood, urine, heart, and for certain infections like HIV or hepatitis to make sure you're healthy enough to take part.

For women who could become pregnant, special precautions will be needed, like using effective contraception. Men will also need to agree to use contraception if their partner could become pregnant. All participants must be able to complete all study visits and provide their written agreement to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old? (Or 18-55 if healthy)
Do you have mild to moderate Parkinson's disease (if applicable)?
Are you generally healthy with no severe health conditions?
Are you willing to attend all scheduled study visits?
Could you agree to use contraception if required for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the study medication (MTX325) or a placebo (a dummy drug). This will be decided by chance, like flipping a coin, and neither you nor the study team will know which you are receiving. You'll need to attend several appointments at the study clinic or hospital.

During these visits, the study team will perform various checks. This will involve things like blood tests, urine tests, checking your heart with an ECG (a simple test to look at your heart's electrical activity), and measuring your vital signs like blood pressure. They'll also monitor any side effects you might experience.

The total duration of the study and how many visits you'll need will depend on which part of the study you are in. Sometimes follow-up visits are also required after you've finished taking the medication. The study team will explain the full schedule and what's involved in detail before you decide to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. While there's no guarantee that MTX325 will help your Parkinson's, your participation could help researchers learn more about the disease and potentially develop new treatments for others in the future. As this is an early-stage study, the full side effects of MTX325 aren't yet known, and there's a chance you might experience unwanted reactions. You will be closely monitored for any issues. It's very important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Royal Liverpool University Hospital
Verified postcode
Liverpool, United Kingdom· Recruiting
Parexel
Verified postcode
London, United Kingdom· Completed
Perceptive
Verified postcode
London, United Kingdom· Completed
Simbec-Orion
Verified postcode
Merthyr Tydfil, United Kingdom· Completed
University Hospitals Plymouth NHS Trust, Derriford Hospital
Verified postcode
Plymouth, United Kingdom· Recruiting

Common questions

What is a 'Phase 1' study?

It's the first stage of testing a new drug in humans. We check if it's safe, how much the body can handle, and how it works, using both healthy people and those with the condition.

What does 'disease-modifying' mean?

It means the treatment aims to slow down, stop, or even reverse the disease itself, not just help with the symptoms.

Will I know if I'm getting MTX325 or a placebo?

No, it's a 'blinded' study. You won't know if you're getting the active drug or a dummy treatment, and neither will the study team.

What is a placebo?

A placebo is a substance that looks exactly like the study medication but doesn't contain any active drug. It helps us compare the real drug's effects.

How long will I be in the study?

The exact duration varies depending on the specific part of the study you join. The study team will explain the full timeline during the consent process.

How to find out more

Sarah J Fritchley, PhD

sfritchley@missiontherapeutics.com Official trial record

Always speak to your GP or specialist before deciding to take part in a study.