RecruitingPHASE2INTERVENTIONAL

Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS)

The AttackMS study aims to see if giving a strong treatment called Natalizumab (Tyruko®) very early on can improve the recovery of damaged nerves in people who are just starting to show symptoms that could be Multiple Sclerosis (MS), or who have just been diagnosed. Currently, there can be a long wait between first symptoms and starting treatment for MS. This study wants to find out if it's possible to give this treatment within 14 days of symptoms appearing and if doing so helps repair the protective coating around nerve fibres (myelin), which is often attacked in MS. By giving early treatment, researchers hope to improve long-term outcomes for people with MS.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Queen Mary University of London

Enrolment target

Start

01 Dec 2022

Estimated completion

31 Oct 2027

Multiple Sclerosis Clinically Isolated Syndrome of Demyelination

What is this study about?

Multiple Sclerosis (MS) is a condition that affects the brain and spinal cord, causing the body's immune system to mistakenly attack the protective layer (called myelin) around nerve fibres. This can lead to a range of symptoms. In the UK, over 130,000 people live with MS. Doctors have found that starting effective treatments early after diagnosis can lead to better long-term health outcomes for people with MS.

However, it often takes some time – sometimes weeks or even months – to get a definite diagnosis of MS, which means treatments can be delayed. This study, called AttackMS, is investigating whether it's possible and beneficial to start a highly effective MS treatment, Natalizumab (known as Tyruko®), much sooner. Specifically, they want to see if this treatment can be given within 14 days of someone first experiencing symptoms that suggest MS, or receiving a definite diagnosis.

The main goals are to see if it's practical to quickly enrol people who are at high risk of developing MS or have definite MS, and if starting treatment so early helps repair the nerve damage. They will measure this repair using a special type of MRI scan. Natalizumab is already approved for use in MS, and this study aims to understand the impact of using it much earlier in the disease journey.

Key takeaways

Tests early use of an effective MS drug (Natalizumab/Tyruko®).
Focuses on people with first MS-like symptoms or new diagnosis.
Aims to start treatment within 14 days of symptom onset.
Measures nerve repair using special MRI scans.
May offer insights into better long-term MS management.

Who may be eligible?

To join this study, participants need to be between 18 and 55 years old. They must also be experiencing their first symptoms that could be MS, or have received a definite MS diagnosis recently. An important requirement is that MRI scans of their brain show at least two damaged areas that are typical of MS.

There are several reasons why someone might not be able to join. These include having a known allergy to the study medication (Tyruko®) or its ingredients, having other serious health conditions like uncontrolled diabetes or heart problems, or having medical implants like a pacemaker that aren't safe for MRI scans. People who are pregnant, breastfeeding, or have a higher risk of infections (for example, if they are taking medicines that suppress their immune system) also cannot take part.

Additionally, combining the study treatment with other MS-modifying treatments is not allowed, nor is participation for those with certain types of cancer (excluding some skin cancers), a history of stroke or blood clots, or severe claustrophobia as MRI scans are required.

Quick self-check

Are you between 18 and 55 years old?
Have you recently experienced your first symptoms that doctors think might be MS, or received a new MS diagnosis?
Do your brain MRI scans show at least two areas of damage typical of MS?
Are you able to attend study visits and MRI scans (e.g., no severe claustrophobia)?
Are you not pregnant or breastfeeding, and not currently on other MS-modifying treatments?

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

What does participation involve?

Taking part in this study would involve several visits to the clinic for assessments and to receive the study medication, Tyruko® (Natalizumab) or a placebo (a dummy treatment). You would have regular MRI scans of your brain, including special types of MRI, to monitor the effects of the treatment on nerve repair. Blood tests would also be taken to check your health and how you're responding to the medication. The study aims to start treatment within 14 days of your symptoms appearing. The total duration of your participation in the study, including follow-up, would be determined by the study protocol, but the initial treatment impact is assessed at 3 months.

Potential risks and benefits

Potential benefits of taking part could include receiving a highly effective MS treatment very early in your disease course, which research suggests might lead to better long-term outcomes. You would also receive regular health monitoring and care from a medical team. However, as with any medication, there are potential risks and side effects associated with Natalizumab. These will be fully explained by the study team, and you will be closely monitored for any adverse reactions. There is also no guarantee that the treatment will be effective for you, or that you will receive the active drug rather than the placebo. Joining a clinical study is always voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Royal London Hospital
London, United Kingdom· Not yet recruiting
St George's Hospital
London, United Kingdom· Recruiting

Common questions

What is Natalizumab (Tyruko®)?

It's a medication approved for treating MS, designed to reduce inflammation and damage to nerve cells.

What is 'Clinically Isolated Syndrome' (CIS)?

This refers to the first time someone experiences symptoms caused by nerve damage in the brain or spinal cord, which could be an early sign of MS.

Why is early treatment important?

Studies suggest that starting effective MS treatment early can help protect nerve cells and reduce the long-term impact of the condition.

Will I definitely get the active drug?

No, this is a 'placebo-controlled' study, meaning some participants will receive the active drug (Tyruko®) and others a dummy treatment (placebo).

What is 'myelin repair'?

Myelin is the protective coating around nerve cells. Myelin repair means the body is fixing this coating after it's been damaged, which is important for nerve function.

How to find out more

Klaus Schmierer

k.schmierer@qmul.ac.uk +44 20 7882 6246 Official trial record

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