RecruitingNAINTERVENTIONAL

Validation of the 18 kiloDalton Translocator Protein (TSPO) as a Novel Neuroimmunodulatory Target

This study is investigating new treatment approaches for Multiple Sclerosis (MS), specifically focusing on secondary progressive MS (SPMS). In MS, the body's immune system attacks the brain. While these attacks stop in SPMS, damage continues. We're exploring a protein called TSPO, which plays a role in immune cells and brain repair. High levels of TSPO are seen in MS. We want to find out if drugs that interact with TSPO can help calm the immune system in SPMS patients. We're testing two drugs, XBD173 and Etifoxine, in people with SPMS and healthy volunteers. Participants will take one drug daily for 7 days, with blood tests before and after to see how the drugs affect immune cells and gene activity.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

01 Jan 2018

Estimated completion

31 Jan 2025

Multiple Sclerosis

What is this study about?

In multiple sclerosis (MS), your immune system mistakenly attacks your brain, causing damage. In a type called secondary progressive MS (SPMS), these attacks might have stopped, but damage to the brain can still continue to happen. This study aims to understand if we can help control this ongoing damage by targeting a specific protein in the body.

This protein is called TSPO and it's found in your immune cells and brain. In MS, levels of TSPO often go up. Researchers believe that if we can use drugs to interact with TSPO, it might be possible to guide immune cells towards helping repair damage rather than causing more. Think of it like trying to switch your immune system from an 'attack' mode to a 'repair' mode. This study will test two different drugs, XBD173 and Etifoxine, to see how they affect this process in people with SPMS and in healthy volunteers.

The main goal is to see if these drugs can change how immune cells behave in a positive way. We also want to compare these effects in people with SPMS to those in healthy volunteers to understand if the drugs work differently depending on a person's immune system. By carefully studying the changes in your blood, researchers hope to learn which drug works best and for whom, potentially paving the way for new treatments for MS.

Key takeaways

This study explores a new way to potentially treat MS by targeting a protein called TSPO.
It involves taking one of two experimental drugs, XBD173 or Etifoxine, for 7 days.
Participation includes visits to Hammersmith Hospital for blood tests.
Both people with SPMS and healthy volunteers are needed.
The goal is to understand how these drugs affect the immune system and gather information for future treatments.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for people aged between 35 and 65 years old. If you have secondary progressive MS (SPMS), your disability level will be checked using a standard scale (EDSS) and needs to be between 3.5 and 6.5. We are also looking for healthy volunteers who meet the age criteria to help us compare results.

There are also some important safety checks. For example, your kidney and liver function will be checked, and if you have certain existing health conditions that might make taking part unsafe, you won't be able to join. Your doctor or the study team will review all your health information carefully to make sure it's safe for you to take part.

Some medications could interfere with the study drugs or tests, so people taking certain drugs (like strong immunosuppressants, some anxiety medications, or blood thinners other than low-dose aspirin) cannot participate. Women who are pregnant or breastfeeding, or who could become pregnant and are unwilling to use contraception, also cannot join the study.

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 between 35 and 65 years old?
Do you have secondary progressive MS (SPMS) or are you a healthy volunteer?
Are you able to avoid alcohol for 7 days?
Are you NOT currently pregnant or breastfeeding?
Are you NOT taking strong immunosuppressant drugs or certain other specific medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first have a screening visit to check if you're suitable. Once confirmed, you will visit the clinical research facility at Hammersmith Hospital. There, you'll be given one of the two study drugs (XBD173 or Etifoxine) to take once a day for 7 days.

Throughout the study, you'll have blood tests. These tests will be done before you start taking the drug and again after you've taken the last dose on day 7. These blood samples will help the researchers understand how the drug affects your immune system and gene activity. You will need to avoid alcohol during the 7 days you are taking the study drug. The total duration of your active participation, including screening and follow-up, would likely span a few weeks, with the main drug-taking period being just one week.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. You might not directly benefit from taking part, but your contribution could help researchers learn more about MS and develop new treatments in the future. The drugs being tested are not licensed for MS, and there may be side effects, though Etifoxine is an anxiety medication in France, and XBD173 has been studied for anxiety. You will be closely monitored by medical staff. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is TSPO?

TSPO is a protein found in your immune cells and brain. Researchers believe it plays a role in how your immune system responds and in brain repair, and its levels can increase in conditions like MS.

What are XBD173 and Etifoxine?

These are the two drugs being tested in the study. They are designed to interact with the TSPO protein. Etifoxine is approved for anxiety in France, but not in the UK. XBD173 is an experimental drug not approved anywhere.

Will these drugs treat my MS?

This is an early-stage study to understand how these drugs affect the immune system in MS. It's not yet known if they can treat MS, but the findings could lead to new treatments in the future.

What does 'secondary progressive MS' mean?

Secondary progressive MS (SPMS) is a stage of MS where symptoms gradually worsen over time, without clear periods of improvement or attacks.

Why are healthy volunteers also included?

Including healthy volunteers helps researchers compare how the drugs affect immune cells in people with MS versus those without, which is important for understanding the drug's full effects.

How to find out more

David Owen, PhD

d.owen@imperial.ac.uk 07801140800 Official trial record

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