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AuthorisedTherapeutic exploratory (Phase II)Interventional

Effects of GLP-1 analogue in multiple sclerosis

This research study is investigating new ways to help people living with multiple sclerosis (MS). Specifically, it's exploring a type of medicine called a GLP-1 analogue, which is typically used for diabetes. Researchers want to understand if these medicines could protect the brain in MS by looking at changes in brain size and a blood marker linked to nerve damage. They also want to see if the medicine can improve thinking and memory skills. The study includes adults aged 18 to 60 who have MS with active disease and are already on their usual MS treatment. It's a 'Phase II' study, which means it's an early-stage trial trying to find out if the treatment is promising and safe.

At a glance

What is this study about?

This study is looking into a new way to potentially help people with multiple sclerosis, or MS. MS is a condition that affects your brain and spinal cord, leading to a range of symptoms. In this study, doctors are investigating a type of medicine that's usually given for diabetes. They want to see if these medicines, called GLP-1 analogues, could also be helpful in managing MS.

Specifically, the researchers are interested in whether these medicines can slow down changes in the brain that are common in MS. They'll measure this by looking at how the size of different parts of the brain changes over time. They'll also check levels of a substance in the blood called neurofilament L, which can be a sign of nerve damage. By tracking these things, they hope to understand if the medicine might offer some protection for the brain.

Beyond just physical changes, the study also aims to see if the medicines can help with 'brain fog' or other thinking and memory problems that some people with MS experience. They will use special tests to check for any improvements in these areas. This is a 'Phase II' study, which means it's an important step in exploring new treatments, but it's still early research.

Key takeaways

  • This study explores if existing diabetes medicines could help people with MS.
  • It aims to see if these medicines can slow down brain changes and improve memory.
  • Participants will continue their current MS treatment alongside the study medicine.
  • It's a 'Phase II' study, meaning it's still in early research stages.
  • Regular clinic visits, blood tests, and MRI scans will be part of the study.

Who may be eligible?

To be considered for this study, you need to have a confirmed diagnosis of multiple sclerosis (MS). The doctors are especially looking for people whose MS is considered more active or likely to get worse, even though they are already on treatment.

You must be between 18 and 60 years old. Your MS should not be too advanced, meaning your level of disability would need to be under a certain score (less than 5 on a scale called EDSS). Also, you need to have been on your current regular MS treatment for at least three months before joining the study.

Men and women are both welcome to take part in this research.

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. Do I have a confirmed diagnosis of multiple sclerosis?
  2. Am I between 18 and 60 years old?
  3. Is my MS considered active, even if I'm on treatment?
  4. Have I been on my current MS treatment for at least the last three months?
  5. Is my level of disability due to MS relatively mild (EDSS score less than 5)?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given one of the study medicines: Rybelsus (as tablets in different strengths) or Trulicity (as an injection using a special pen). These medicines are typically taken regularly, either daily or weekly, depending on which one you are assigned. You would continue to take your regular MS treatment throughout the study.

The study would involve several visits to the clinic. At these visits, doctors and nurses would perform various assessments. These would include blood tests to check your neurofilament L levels and other markers, as well as MRI scans to measure your brain volume. You would also complete computer-based tests, like the Symbol Digit Modalities Test and Stroop Test, to assess your thinking and memory skills. The total duration of your participation in the study would be outlined by the research team.

Potential risks and benefits

Participating in research studies like this can offer potential benefits, such as contributing to medical knowledge that could help future MS patients and gaining close medical monitoring during the study. However, there are also potential risks; for example, the study medicines may have side effects, some of which are not yet fully known in people with MS. It's important to remember that 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
    Slovakia

Common questions

What is MS?

MS, or multiple sclerosis, is a condition that affects your brain and spinal cord, which can cause symptoms like tiredness, numbness, problems with balance, vision, and walking.

What is Rybelsus or Trulicity?

These are medicines usually prescribed to help people with type 2 diabetes manage their blood sugar. This study is exploring if they might also help with MS.

What does 'brain volume' mean?

Measuring 'brain volume' helps doctors see if parts of your brain are shrinking or changing, which can happen in MS. It’s measured using special scans like an MRI.

What is a 'Phase II' study?

A Phase II study is an early stage of clinical research. It means doctors are trying to find out if a new treatment is effective and safe, but it's not yet widely available.

Will I stop my current MS treatment?

No, you would continue to take your regular MS treatment throughout this study. The study medicine would be given in addition to your current treatment.

How to find out more

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

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