Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sc… (NCT05418010) | Clinical Trial Compass
RecruitingPhase 2
Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS)
United Kingdom40 participantsStarted 2022-12-01
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Hypersensitivity to Tyruko® or to any of the following excipients:
✕. 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..
What they're measuring
1
To establish whether there is efficacy superiority of Natalizumab (Tyruko®) over placebo at 12 weeks in facilitating remyelination of previously demyelinated CNS lesions, as measured by MRI lesion magnetization transfer ratio (MTR).