All studies
Active not recruitingPHASE3INTERVENTIONAL

A Trial of Amlenetug (Lu AF82422) in Participants With Multiple System Atrophy (MSA)

This study is looking into a new treatment called Amlenetug for a serious condition called Multiple System Atrophy (MSA). MSA affects the nervous system and can cause problems with movement, balance, and other body functions. The main goal is to find out if Amlenetug is safe to use and if it can help improve the symptoms or slow down the progression of MSA. Participants will receive the study treatment as an infusion into a vein at regular intervals. Some people will receive the active medicine, while others will receive a placebo (a dummy treatment) to allow researchers to accurately compare its effects. This study is for people aged 40 to 75 years old.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
H. Lundbeck A/S
Enrolment target
401
Start
03 Dec 2024
Estimated completion
25 Oct 2029

What is this study about?

This research study is investigating a new medication called Amlenetug for people who have been diagnosed with Multiple System Atrophy (MSA). MSA is a rare and serious condition that affects your nervous system. It can cause a range of problems, like difficulty with movement, balance, blood pressure, and bladder control.

The main purpose of this study is to see how well Amlenetug works and if it's safe for people with MSA. We're hoping to understand if this new medicine can help manage the symptoms of MSA or potentially slow down how quickly the condition progresses. The study will compare Amlenetug with a 'placebo', which is a substance that looks exactly like the study medicine but doesn't contain any active ingredients. This comparison helps us understand if any changes observed are truly due to Amlenetug or if they might happen anyway.

Taking part in a study like this helps doctors learn more about MSA and develop new ways to treat it. Every participant's contribution is valuable, as it helps advance medical knowledge and could potentially lead to better treatments for others in the future.

Key takeaways

  • This study is testing a new medicine (Amlenetug) for Multiple System Atrophy (MSA).
  • It aims to see if Amlenetug is safe and effective for people with MSA.
  • Participation involves regular infusions and health check-ups over a long period.
  • Some participants will receive a dummy treatment (placebo) for comparison.
  • The study is for people aged 40-75 with recently diagnosed MSA.
  • You can stop participating at any time if you change your mind.

Who may be eligible?

To be considered for this study, you would generally need to be between 40 and 75 years old and have a confirmed diagnosis of Multiple System Atrophy (MSA), either the Parkinsonian type (MSA-P) or the Cerebellar type (MSA-C). Your MSA symptoms should have started within the last five years, and your doctor should believe you are likely to live for at least another three years.

There are also some reasons why you might not be able to join. For example, if you've previously taken this specific study medicine (Amlenetug), or if you're taking another experimental treatment. Also, if you have other serious medical conditions that might affect your brain or nervous system, or a family history of MSA in several close relatives, you might not be able to take part. Researchers also check for other movement disorders that could be mistaken for MSA.

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.

  1. Are you between 40 and 75 years old?
  2. Do you have a confirmed diagnosis of Multiple System Atrophy (MSA)?
  3. Did your MSA symptoms start within the last five years?
  4. Have you *not* taken part in a study for this specific medicine before?
  5. Do you *not* have other serious medical conditions that might affect your brain?
  6. Do you *not* have two or more close relatives who have had MSA?
Answer every question to see your result.

What does participation involve?

If you join this study, it will involve several stages. First, there's a screening period lasting between 10 days and up to 6 weeks to ensure you meet all the requirements. After that, there's a main treatment period of 72 weeks where you'll receive either Amlenetug or a placebo. You won't know which one you're getting during this time.

During both the main treatment period and an optional extended period, you will receive the study medicine as an infusion directly into a vein. These infusions will happen approximately every four weeks. If you choose to continue into the optional extended treatment period, which also lasts 72 weeks, everyone will receive Amlenetug during this phase. Throughout the study, you'll have regular visits where doctors will monitor your health, check your symptoms, and take blood samples to see how you're responding to the treatment.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new potential treatment that isn't yet widely available, and you'll receive close medical monitoring. However, there's no guarantee that the treatment will help everyone, and it might not work for you. There is also a risk of side effects from the study medication, though these will be carefully monitored. You will receive all the necessary information about potential risks before deciding to join, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (74)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Mayo Clinic
    Verified postcode
    Scottsdale, United States
  • University of Arkansas for Medical Sciences
    Verified postcode
    Little Rock, United States
  • University of California, San Francisco Neurosciences Clinical Research Unit
    Verified postcode
    San Francisco, United States
  • CenExel Rocky Mountain Clinical Research, LLC
    Verified postcode
    Englewood, United States
  • Yale New Haven Health
    Verified postcode
    North Haven, United States
  • Parkinson's Disease And Movement Disorder Center Of Boca Raton
    Verified postcode
    Boca Raton, United States
  • University of Florida Norman Fixel Institute for Neurological Diseases
    Verified postcode
    Gainesville, United States
  • Indiana Health University
    Verified postcode
    Indianapolis, United States
  • Johns Hopkins University School of Medicine
    Verified postcode
    Baltimore, United States
  • Brigham and Women's Hospital
    Verified postcode
    Boston, United States
  • Beth Israel Deaconess Medical Center
    Verified postcode
    Boston, United States
  • QUEST Research Institute
    Verified postcode
    Farmington Hills, United States

Common questions

What is Multiple System Atrophy (MSA)?

MSA is a rare and progressive condition affecting the nervous system, leading to problems with movement, balance, and involuntary body functions like blood pressure and bladder control.

What is Amlenetug?

Amlenetug is the new medicine being tested in this study to see if it can help people with Multiple System Atrophy.

What is a 'placebo'?

A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It's used to compare the effects of the active drug accurately.

How will I receive the study medicine?

The study medicine will be given as an infusion into a vein, roughly once a month, throughout the study periods.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, for any reason, without affecting your medical care.

How to find out more

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

Discussion

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