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New treatment option for Multiple Sclerosis
Official title Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS)
ClinicalTrials.gov ID: NCT05418010
What this study is testing
What is Tyruko Injectable Product?
Tyruko Injectable Product is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple sclerosis.
Also referred to as Natalizumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 20 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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.
You likely can't join if
- Hypersensitivity to Tyruko® or to any of the following excipients:
- Histidine
- Histidine monohydrochloride
- Sodium chloride
- Polysorbate 80 (E433)
- Water for injections
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 20 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.