NCT05418010RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 7 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 17 Feb 2022
- Start date
- 1 Dec 2022
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Queen Mary University of London
- Diseases
- Multiple sclerosis
- NCT number
- NCT05418010
- EudraCT number
- 2021-002255-11
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 1 Dec 2022 to the primary completion date, 31 Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with increased risk for opportunistic infections, including immunocompromised participants (those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).
Other illness
- Combination with other Disease Modifying Treatments..
- Known active malignancies, except for participants with cutaneous basal cell carcinoma.
- Implants such as pacemaker, aneurysm clip in the brain and MRI-incompatible prosthetic heart valves.
- Significant comorbidities such as cardiac failure, renal failure, uncontrolled diabetes and uncontrolled hypercholesterolemia.
- History of stroke, thrombosis and/or myocardial infarction.
- Any other infection deemed, in the assessment of the PI or sub-investigator, clinically significant.
Lab values
- Hypersensitivity to Tyruko® or to any of the following excipients:
- Histidine
- Histidine monohydrochloride
- Sodium chloride
- Polysorbate 80 (E433)
- Water for injections
Other
- Evidence of multiple chronic demyelinating lesions on MRI without signs of recent activity.
- Claustrophobia
- Pregnancy or breastfeeding
Who the study is looking for
- Participant has provided informed consent.
- Age 18-55 years
- Participant with CIS or MS at first presentation.
- Participants show two or more lesions on T2 weighted MRI suggestive of demyelination.
- Participant is willing and able to comply with clinical visits and procedures outlined in the study protocol.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. George's Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Royal London Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.