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

PHASE2SuspendedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 1, 2022

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
Multiple SclerosisClinically Isolated Syndrome of Demyelination
Interventions
DRUG

Tysabri Injectable Product

Tysabri® is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis. Tysabri® 300mg concentrate for solution for infusion and matching placebo are collectively referred to as IMP when detailing to blinded trial procedures. Tysabri® 300mg will be colourless, clear to slightly opalescent solution.

DRUG

Placebo

Placebo is colourless, clear to slightly opalescent liquid. The formulation of the is the same as that of commercial Tysabri® minus the active ingredient. Placebo is in the same containers/vials as Tysabri®.

Trial Locations (1)

E1 1FR

Royal London Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Biogen

INDUSTRY

collaborator

UCL Queen Square Institute of Neurology

OTHER

collaborator

Moorfields Eye Hospital NHS Foundation Trust

OTHER

collaborator

Barts & The London NHS Trust

OTHER

lead

Queen Mary University of London

OTHER