Neuromyelitis Optica Clinical Trial
Official title:
A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and Children
This multi-center randomized controlled trial evaluates if the addition of intravenous immunoglobulin to standard treatment of corticosteroids improves outcome in children and adults with first episode of Transverse Myelitis of Neuro-myelitis optica. Half of participants will receive corticosteroids alone, whilst the other half will receive corticosteroids plus intravenous immunoglobulin.
Transverse myelitis (TM) is a severe demyelinating condition predominantly affecting young
people, which causes significant long-term disability in approximately one third. Current
initial treatment is with corticosteroids, although evidence for their use is based on
extrapolation from trials in adult multiple sclerosis relapses. In view of the severity of
the condition, additional treatments have been trialed.
Intravenous immunoglobulin (IVIG) is often used as second-line treatment in
steroid-unresponsive central nervous system demyelination, although evidence for its
efficacy is limited to small case series and case reports. Randomized controlled trials have
demonstrated that IVIG reduces inflammation and enhances remyelination in a number of
neurological conditions, although there have been no randomized controlled trials testing
its use in adults and children with TM.
This study will evaluate if additional and early treatment with IVIG is of extra benefit in
TM when compared to the current standard therapy of intravenous steroids alone.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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