AttackMS
What it found
No result yet.
What was tested
Treatment tested
- Natalizumab
Integrin alpha-4/beta-1 inhibitor|Integrin alpha-4/beta-7 inhibitor
Placebo or sham
- Placebo
What it measured
Main measures
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).
12 weeks
MRI lesionsMyelin repair
Other measures (5)
To establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in P100 latency measured using visually evoked potentials (VEP).
0 and 24 weeks
Myelin repairTo establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in number and occurrence of adverse events.
24 weeks
SafetyTo establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in facilitating remyelination of previously demyelinated CNS lesions using Magnetisation transfer ratio (MTR).
0, 12 and/or 24 weeks
MRI lesionsMyelin repairTo establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in protecting limb function.
24 weeks
Disability progressionBlood or spinal fluid markersThinking and memoryFatigueWalking and mobilityTo establish whether there is a difference between participants receiving Natalizumab (Tyruko®) or placebo at 24 weeks in Retinal nerve fibre layer ganglion cell + inner plexiform (GCIP) layer thickness measured using optical coherence tomography (OCT).
O and 24 weeks
Retina scans (OCT)
Who could take part
Early (CIS/RIS) · 18 to 55
Inclusion Criteria: 1. Participant has provided informed consent. 2. Age 18-55 years 3. Participant with CIS or MS at first presentation. 4. Participants show two or more lesions on T2 weighted MRI suggestive of demyelination. 5. Participant is willing and able to comply with clinical visits and procedures outlined in the study protocol. Exclusion Criteria: 1. Hypersensitivity to Tyruko® or to any of the following excipients: * Histidine * Histidine monohydrochloride * Sodium chloride * Polysorbate 80 (E433) * Water for injections 2. Evidence of multiple chronic demyelinating lesions on MRI without signs of recent activity. 3. Participants with increased risk for opportunistic infections, including immunocompromised participants (those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies). 4. Combination with other Disease Modifying Treatments.. 5. Known active malignancies, except for participants with cutaneous basal cell carcinoma. 6. Implants such as pacemaker, aneurysm clip in the brain and MRI-incompatible prosthetic heart valves. 7. Significant comorbidities such as cardiac failure, renal failure, uncontrolled diabetes and uncontrolled hypercholesterolemia. 8. History of stroke, thrombosis and/or myocardial infarction. 9. Any other infection deemed, in the assessment of the PI or sub-investigator, clinically significant. 10. Claustrophobia 11. Pregnancy or breastfeeding
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
Papers
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Phase 4 · Completed
No result found
History
Started
Dec 2022
Main results due
Oct 2027
Finished
Oct 2027
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