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Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Magnet Study - A Multi-arm, Adaptive, Group-sequential trial NETwork to evaluate drug efficacy in patients with Amyotrophic Lateral Sclerosis (ALS)

The Magnet Study is a research project for people with ALS, also known as Motor Neurone Disease. Researchers want to find out if a drug called Lithium can help people with ALS live longer or delay serious breathing problems. They will compare Lithium to a 'dummy' pill, which looks the same but contains no active medicine. This is a large-scale study (Phase III), meaning it's one of the final steps to see if the treatment works and is safe. The main thing they will measure is how long people live, or how long it takes before they need significant help with their breathing. They will also look at daily activities, breathing strength, quality of life, and how safe the drug is.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Stichting TRICALS Foundation
Enrolment target
75
Start
08 Nov 2024

What is this study about?

The Magnet Study is an important research trial for people living with Amyotrophic Lateral Sclerosis (ALS), often known as Motor Neurone Disease in the UK. The main goal of this study is to investigate whether a specific medication, Lithium, can help improve the lives of people with ALS. Researchers are particularly interested in seeing if it can help people live longer or prevent them from needing significant help with their breathing due to the condition. This is a 'Phase III' trial, which means it’s a big study involving many people, designed to confirm if the treatment is effective and safe before it could potentially be made widely available.

Participants in the study will be given either the active drug, Lithium, or a placebo. A placebo is a 'dummy pill' that looks identical to the active drug but contains no medicine. This is a common and important part of clinical trials, as it helps researchers accurately tell if any changes seen are truly due to the drug itself or other factors. Both the active drug and the placebo capsules will contain common, safe ingredients that are often used in medicines.

The researchers will also be carefully monitoring several aspects of participants' health throughout the study. Besides looking at how long people live, they will assess daily activities, breathing strength, overall quality of life, and any changes in thinking abilities. Importantly, they will also keep a very close eye on the safety of the drug, checking for any side effects or unwanted reactions to make sure the treatment is well-tolerated.

Key takeaways

  • The Magnet Study is testing a drug called Lithium for ALS.
  • It aims to see if Lithium can help people with ALS live longer or improve breathing.
  • Participants will receive either Lithium or a 'dummy' pill (placebo).
  • It's a large-scale (Phase III) study for adults aged 18 and over.
  • They will monitor daily activities, breathing, quality of life, and drug safety.
  • Participation involves regular clinic visits and health checks.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years or older. There is no upper age limit, so people of all adult ages are welcome to consider taking part. Both men and women can join the study.

While the basic requirements are straightforward, there will be other specific things that the study doctors will need to check. These might include your current health status, any other medications you are taking, and how your ALS is affecting you at the moment. These checks are important to make sure the study medication is suitable and safe for you, and that the results of the trial are clear and accurate.

Quick self-check
  • Are you 18 years old or older?
  • Do you have a diagnosis of ALS (Motor Neurone Disease)?
  • Are you able to attend regular clinic appointments?
  • Are you willing to take capsules as instructed?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the Magnet Study, you would be asked to take capsules, either the active drug or a placebo, as instructed by the study team. You would have regular appointments at the study clinic where doctors and nurses would check on your health, your breathing, and how you are managing daily activities. They would also ask you to complete questionnaires about your quality of life. You would likely have blood tests and other examinations to monitor your health and how the treatment is affecting you. The total length of your participation would depend on the study design, and the study team will explain everything to you in detail.

Potential risks and benefits

Participating in a clinical trial may offer some potential benefits, such as contributing to medical knowledge that could ultimately help others with ALS, and receiving close medical monitoring. However, there's no guarantee that the treatment will help you personally, and you might receive a placebo. There's also the chance of experiencing side effects from the medication. The study team will explain all known side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

  • Sweden
  • Netherlands
  • Spain
  • Belgium

Common questions

What is ALS?

ALS, or Amyotrophic Lateral Sclerosis, is a progressive condition that affects the nerves in the brain and spinal cord, leading to muscle weakness and wasting.

What is a 'Phase III' trial?

A Phase III trial is a large study that compares a new treatment to an existing one, or to a placebo, to confirm if it's effective and safe before it can be made available to everyone.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active drug. It helps researchers understand if the new drug is truly working.

What will the study measure?

The study will mainly look at how long people live or how quickly their breathing changes. It will also check daily activities, breathing strength, quality of life, and safety.

Can I choose to receive the active drug?

No, in this type of study, participants are randomly assigned to receive either the active drug or the placebo. This helps ensure the study results are fair and unbiased.

How to find out more

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

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