Status:
RECRUITING
Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS)
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
Biogen
UCL Queen Square Institute of Neurology
Conditions:
Multiple Sclerosis
Clinically Isolated Syndrome of Demyelination
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 betw...
Detailed Description
MS is a disease of the central nervous system affecting over 130,000 people in the UK and more than 2.8 million worldwide. Left untreated, MS leads to chronic disability in the large majority of cases...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Hypersensitivity to Tyruko® or to any of the following excipients:
- Histidine
- Histidine monohydrochloride
- Sodium chloride
- Polysorbate 80 (E433)
- Water for injections
- Evidence of multiple chronic demyelinating lesions on MRI without signs of recent activity.
- Participants with increased risk for opportunistic infections, including immunocompromised participants (those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies).
- 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.
- Claustrophobia
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
December 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05418010
Start Date
December 1 2022
End Date
October 31 2027
Last Update
January 7 2026
Active Locations (2)
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1
Royal London Hospital
London, United Kingdom, E1 1FR
2
St George's Hospital
London, United Kingdom, SW17 0QT