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Natalizumab for the Treatment of People With Inflammatory Demyelination Suggestive of Multiple Sclerosis, or Definite Multiple Sclerosis, at First Presentation (AttackMS)

Study acronym: AttackMS
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Trial status: Suspended to Recruitingv7 Show 7 more changesShow less
    • Primary endpoint revised
    • Study sites: 1 to 2
    • Primary and study completion dates: Jan 31, 2028 to Oct 31, 2027
    • Interventions: Placebo (Drug), Tysabri Injectable Product (Drug) to Placebo (Drug), Tyruko Injectable Product (Drug)
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints revised (5)
    • Study description revised
  2. Primary and study completion dates: Jan 31, 2025 to Jan 31, 2028
    • Sponsor's reason: Trial to Trial hoping to restart May 2025
    v6
  3. Trial status: Recruiting to Suspended Sponsor's reason: Trial
    • Primary and study completion dates: May 31, 2024 to Jan 31, 2025
    • Site details revised
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 30, 2022 to Dec 1, 2022
    v3
  6. Primary completion date: Aug 31, 2023 to May 31, 2024v2 Show 5 more changesShow less
    • Start date: Jul 31, 2022 to Nov 30, 2022
    • Study completion date: Aug 31, 2024 to May 31, 2024
    • Study description expanded, about 423 words
    • Collaborators expanded, about 19 words
    • Study title expanded, about 4 words
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05418010
Lead Sponsor Queen Mary University of London
Collaborators: Biogen, UCL Queen Square Institute of Neurology, Moorfields Eye Hospital NHS Foundation Trust, Barts & The London NHS Trust
Conditions
(from sponsor)		 Multiple Sclerosis, Clinically Isolated Syndrome of Demyelination
Related terms Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Charcot-Marie-Tooth disease, Type 1F, Demyelinating Diseases, Immune System Diseases, Multiple Sclerosis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov