AuthorisedTherapeutic exploratory (Phase II)Interventional

Open-Label Extension Study to Provide Access to ATH434 in Patients with Multiple System Atrophy

This ongoing study is giving access to a medicine called ATH434 for people living with Multiple System Atrophy (MSA). It’s an extended study, meaning it follows on from an earlier trial, to see how people respond to the medicine over a longer period. The main goal is to understand if ATH434 is safe when taken for a long time and if people can tolerate it well. Researchers will carefully watch for any side effects, both mild and serious. They will also check general health through blood tests, blood pressure readings (especially when standing up), and other measures. This helps them understand the overall safety profile of the medicine and how it affects people with MSA.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Alterity Therapeutics Limited

Enrolment target

Start

13 May 2026

Multiple System Atrophy

What is this study about?

This is an ongoing study for people with a condition called Multiple System Atrophy, also known as MSA. MSA is a rare and serious brain condition that affects many body functions, including movement, balance, and automatic processes like blood pressure and bladder control. The study is offering continued access to a medicine called ATH434.

The main purpose of this study is to find out more about how safe ATH434 is when taken for a long time. Researchers want to see if people can take this medicine over an extended period without too many problems. They are carefully looking at any side effects that might happen, whether they are minor or more serious. They will also check important health signs like blood pressure and do laboratory tests to make sure the medicine isn't causing any hidden issues.

This kind of study, where participants continue on an experimental medicine after an initial trial, is important. It helps doctors understand the potential long-term effects and benefits, which is crucial before a medicine can become widely available. Your participation helps gather vital information to help others with MSA in the future.

Key takeaways

This study is an 'extension' to continue giving ATH434 to people with MSA.
The main goal is to check the long-term safety and how well people tolerate the medicine.
Researchers will monitor side effects, blood pressure, and other lab tests.
It helps gather important long-term information about ATH434 for MSA.
Participation helps future patients, but there's no guarantee of personal benefit.

Who may be eligible?

To join this study, you need to be an adult, at least 18 years old. There's no upper age limit, meaning older adults can also take part.

Both men and women are welcome to be part of this research. The study aims to include a wide range of people to understand how the medicine affects different individuals.

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 18 years old or older?
Do you have a diagnosis of Multiple System Atrophy (MSA)?
Have you participated in a previous study involving ATH434?
Are you able to attend regular study appointments?

Answer every question to see your result.

What does participation involve?

This study is an extension, meaning participants have likely been in a previous study with ATH434. The main focus is on long-term safety. This generally involves regular visits to the study clinic, where you would have health checks, blood tests, and assessments of any side effects. You would continue to take the study medication, ATH434. The duration of your participation would depend on the study design, but these types of extension studies can last for several months or even a few years, with ongoing follow-up.

Potential risks and benefits

Taking part in this study could offer you continued access to a potential new treatment for MSA, which may or may not help your condition. However, there are potential risks, including side effects from the medication, which could be mild or severe. There's also the chance the medicine won't work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is Multiple System Atrophy (MSA)?

MSA is a rare brain condition that affects movement, balance, and automatic body functions like blood pressure and bladder control.

What is ATH434?

ATH434 is a medicine being tested to see if it can help people with Multiple System Atrophy. It's not yet available outside of clinical trials.

What does 'Open-Label' mean?

'Open-Label' means that both you and the study doctors will know you are receiving the active medicine, ATH434. No placebos are used in this part of the study.

What is a 'Phase II' study?

Phase II studies are usually the early stages where a new medicine is tested in people to see if it's safe, how well it's tolerated, and if it shows any promising signs of working.

Will I have to pay to be in this study?

No, you will not have to pay for the study medication or the study-related visits and tests. Travel expenses are often covered, but you should confirm this with the study team.