RecruitingPhase 2NCT05418010

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

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


Sponsor

Queen Mary University of London

Enrollment

40 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Multiple Sclerosis (MS) is a chronic inflammatory \& degenerative disease of the central nervous system (CNS) Recent data from the MS Base registry demonstrated an average delay of 152 - 215 days between first presentation and the diagnosis of MS, and more than one year until Disease Modifying Treatment (DMT) begins. Evidence suggests that shutting down inflammation using highly effective DMTs early after diagnosis leads to better long term clinical outcomes The AttackMS trial will test the effect of starting a highly-effective DMT licensed for MS, Tyruko® (Natalizumab 300mg), within a short time - 14 days - after symptom onset.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing natalizumab — a medication that reduces inflammation in the brain and spinal cord — in people who have just experienced their first neurological episode that may be multiple sclerosis (MS) or is strongly suggestive of it. The goal is to see if early aggressive treatment can slow or prevent the disease from progressing. **You may be eligible if...** - You are between 18 and 55 years old - You are experiencing your first episode of neurological symptoms that suggest MS or a condition called clinically isolated syndrome (CIS) - You have 2 or more lesions on brain MRI consistent with demyelination (nerve damage) - You are willing to attend regular clinic visits and complete study requirements **You may NOT be eligible if...** - You have a confirmed diagnosis of MS that is not at first presentation - You have already started MS disease-modifying treatment - You are pregnant or breastfeeding - You have significant health conditions that make natalizumab unsafe (e.g., liver disease, active infections) - You have a history of serious allergic reactions to this type of medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTyruko Injectable Product

Tyruko® is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis. Tyruko® 300mg concentrate for solution for infusion and matching placebo are collectively referred to as IMP when detailing to blinded trial procedures. Tyruko® 300mg will be colourless, clear to slightly opalescent solution.

DRUGPlacebo

Placebo is colourless, clear to slightly opalescent liquid. The formulation of the is the same as that of commercial Tyruko® minus the active ingredient. Placebo is in the same containers/vials as Tyruko®.


Locations(2)

Royal London Hospital

London, United Kingdom

St George's Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05418010


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