Clinical Trial: A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and Children
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Current Primary Outcome: 2 points or greater improvement on the American Spinal Injury Association (ASIA) Impairment scale (classified A-E) [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Guy's and St Thomas' NHS Foundation Trust
Dates:
Date Received: March 23, 2015
Date Started: March 2015
Date Completion:
Last Updated: July 18, 2016
Last Verified: July 2016