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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
2 points or greater improvement on the American Spinal Injury Association (ASIA) Impairment scale (classified A-E)
Time frame: 6 months
Change in ASIA motor scale (0-100) and ASIA sensory scale (0-112)
Time frame: 6 months
Change in Kurtzke's expanded disability status scale (EDSS) measured with Neurostatus scoring
Time frame: 6 months
EQ-5D-Y (for patients aged 8-12 years at presentation)
Time frame: 6 months
EQ-5D-5L (for patients aged 13 years or over at presentation)
Time frame: 6 months
International Spinal Cord Injury (SCI) Quality of Life Basic Data Set (for patients aged 13 years or over at presentation)
Time frame: 6 months
Client Service Receipt Inventory (CSRI)
Time frame: 6 months
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