Nervous System Diseases

Eye Diseases

Immune System Diseases

All Conditions

Infections

Neoplasms

Symptoms and General Pathology

Rare Diseases

Neuromyelitis Optica

Myelitis

Myelitis, Transverse

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Neuritis

Optic Neuritis

Optic Nerve Diseases

Cranial Nerve Diseases

Demyelinating Diseases

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Central Nervous System Diseases

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Neuroinflammatory Diseases

Syndrome

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Paraneoplastic Syndromes, Nervous System

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Neuromyelitis Optica Spectrum Disorder

Transverse Myelitis

All Drugs and Chemicals

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Prednisolone

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Methylprednisolone

Methylprednisolone Acetate

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Immunoglobulins, Intravenous

gamma-Globulins

Rho(D) Immune Globulin

Glucocorticoids

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Hormone Antagonists

Protective Agents

Immunologic Factors

Paediatric patients - 30mg/kg or 500mg/m2 up to a maximum daily dose of 1g/day for 5 days.

Adult patients - 1g/day for 5 days.

Paediatric patients \<41.2kg - total dose of 2g/kg in divided doses over 2 days.

All other patients - total dose of 2g/kg in divided doses over 5 days.

PLUS Intravenous Methylprednisolone

Pediatric patients - 30mg/kg or 500mg/m2 up to a maximum daily dose of 1g/day for 5 days.

Adult patients - 1g/day for 5 days.

Intravenous Methylprednisolone

Intravenous Immunoglobulin

Ming Lim, MB, PhD

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.

A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis

A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and Children

King's College London

Barts and the London School of Medicine and Dentistry

Cardiff University

University College, London

King's College Hospital NHS Trust

Great Ormond Street Hospital for Children NHS Foundation Trust

Barts & The London NHS Trust

Alder Hey Children's NHS Foundation Trust

Walton Centre NHS Foundation Trust

Oxford University Hospitals NHS Trust

Birmingham Women's and Children's NHS Foundation Trust

University Hospital Birmingham NHS Foundation Trust

Cardiff and Vale University Health Board

North Bristol NHS Trust

University Hospitals Bristol and Weston NHS Foundation Trust

Manchester University NHS Foundation Trust

Northern Care Alliance NHS Foundation Trust

University Hospital Southampton NHS Foundation Trust

Newcastle-upon-Tyne Hospitals NHS Trust

Nottingham University Hospitals NHS Trust

NHS Lothian

Guy's and St Thomas' NHS Foundation Trust

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis	NCT02398994	Myelitis, Trans... Neuromyelitis O...	Intravenous Met... Intravenous Imm...	1 Year -	Guy's and St Thomas' NHS Foundation Trust
A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis	NCT02398994	Myelitis, Trans... Neuromyelitis O...	Intravenous Met... Intravenous Imm...	1 Year -	Guy's and St Thomas' NHS Foundation Trust

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