AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomized, Phase 2a, double-blinded, biomarker-driven, placebo-controlled study to assess safety, CNS penetration, and target engagement of Mirivadelgat in Parkinson’s disease – SLEIPNIR-2, a sub-protocol in the SLEIPNIR platform trial

This research is testing a new medication called Mirivadelgat for people with Parkinson's disease. It's an early-stage study (Phase II) designed to understand if the medicine is safe and how it works in the body, particularly in the brain. Researchers will check for any side effects and see if the medicine reaches the brain as expected. They will also look at whether it helps with certain markers in the brain that are linked to Parkinson's. Some participants will receive Mirivadelgat, while others will receive a placebo, which looks like the medicine but contains no active ingredient. This helps researchers accurately see the effects of Mirivadelgat. The aim is to gather important information to see if this medicine could be a promising treatment in the future.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Helse Bergen HF

Enrolment target

Start

02 Jun 2026

Parkinson's Disease

What is this study about?

This clinical trial, called SLEIPNIR-2, is a research study focused on Parkinson's disease. The main goal is to test a new medicine, Mirivadelgat, to see how safe it is, how well it gets into the brain, and if it affects specific processes in brain cells that are thought to play a role in Parkinson's. Understanding these things is really important to decide if Mirivadelgat could be a helpful treatment option later on.

In this study, participants will either receive Mirivadelgat or a 'placebo'. A placebo is a dummy pill that looks exactly like the actual medicine but doesn't contain any active ingredients. This is a common and important part of clinical trials because it allows researchers to accurately compare the effects of the new medicine against no treatment. No one will know whether they are receiving the drug or the placebo, which helps ensure the results are unbiased.

The researchers will closely monitor participants for any side effects – both minor and serious ones. They will also collect samples, like spinal fluid, to measure how much of the medicine reaches the brain and to check for changes in certain biological markers. These markers, such as levels of 4-HNE or certain brain energy measurements, can give clues about how Parkinson's disease affects the brain and if the medicine is having a positive effect on these processes. This early-stage research is crucial for understanding if Mirivadelgat has potential as a future treatment for Parkinson's.

Key takeaways

This study is testing a new medicine called Mirivadelgat for Parkinson's disease.
It's an early-stage study to check safety and how the medicine works in the body and brain.
You might receive the new medicine or a dummy pill (placebo).
Participation involves regular clinic visits, assessments, and taking the study medicine.
Measurements will include blood, spinal fluid samples, and special brain scans.
Your involvement helps advance understanding and potential treatments for Parkinson's.

Who may be eligible?

To join this study, you need to be an adult, aged 18 years or older. There is no upper age limit, so people of all adult ages can be considered. The study is open to both men and women.

Beyond these basic requirements, there will be more specific criteria that decide if you are a good fit for this particular study. These often include things like your current health conditions, any other medications you are taking, and how your Parkinson's disease has progressed. These detailed rules help make sure the study is safe for you and that the results are clear.

It's important to discuss your full medical history with the study doctors to see if you meet all the requirements. They will explain everything clearly and answer any questions you have about whether this study is right for you.

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 Parkinson's disease?
Are you able to commit to regular clinic visits and assessments?
Are you comfortable with the possibility of receiving a placebo?
Are you willing to undergo blood tests and spinal fluid collection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the new medicine, Mirivadelgat, or a placebo (a dummy pill with no active ingredient) for a period of 12 weeks. You will be asked to take the study medicine regularly as instructed. During this time, you will have several visits to the clinic for assessments.

These assessments will include regular checks for any side effects, both minor and serious. Doctors will also collect samples, such as blood and spinal fluid, to measure how the drug is working in your body and brain. You will also undergo special brain scans using a technique called phosphorus magnetic resonance spectroscopy (31P-MRS), which helps us look at how your brain cells are using energy. After the 12 weeks of treatment, there will likely be follow-up visits to continue monitoring your health. The total duration of your involvement, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and potential risks. A possible benefit of joining this study is that you might receive access to a new medicine that could potentially help with your Parkinson's disease, although this is not guaranteed as it's still being tested. Your participation will also directly help researchers learn more about Parkinson's and contribute to finding better treatments for everyone. On the other hand, there might be side effects from the medicine, whether known or unknown, and there's a chance the medicine may not help you. There could also be slight discomfort or risks from tests like blood draws or spinal fluid collection. 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.

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Unverified
Norway

Common questions

What is Parkinson's disease?

Parkinson's disease is a condition that affects the brain, causing problems with movement like shaking, stiffness, and difficulty with balance and walking.

What is a 'placebo'?

A placebo is a pill or treatment that looks exactly like the real medicine but contains no active ingredients. It's used in studies to compare the effects of the new medicine fairly.

What does 'Phase II' mean for this study?

Phase II means this is an early stage of testing for a new medicine. Researchers are mainly looking at its safety and how well it works in the body for the first time in a larger group of people.

Will I know if I'm getting the medicine or the placebo?

No, in this type of 'double-blind' study, neither you nor the study team will know whether you are receiving the active medicine or the placebo. This helps make the study results as accurate as possible.

What is meant by 'spinal fluid' measurements?

Spinal fluid, also called cerebrospinal fluid (CSF), is the fluid that surrounds your brain and spinal cord. Collecting a small sample can help researchers understand how the medicine is working in the brain.