A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy f… (NCT02398994) | Clinical Trial Compass
TerminatedPhase 3
A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis
Stopped: Continued effort did not successfully increase recruitment into the study.
United Kingdom2 participantsStarted 2015-03
Plain-language 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.
Who can participate
Age range1 Year
SexALL
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Inclusion Criteria:
* Diagnosis of
EITHER acute first onset transverse myelitis (using the TM Consortium Working Group 2002 criteria) - patients must fulfill all of the following criteria:
* Sensory, motor, or autonomic dysfunction attributable to spinal cord disease
* Bilateral signs and/or symptoms (not necessarily symmetric)
* Sensory level (except in young children \<5 years where this is difficult to evaluate)
* Lack of MRI brain criteria consistent with multiple sclerosis
* Progression to nadir between 4 h and 21 days
OR first presentation of neuromyelitis optica (using standardised criteria) - patients must fulfil both absolute criteria:
* Optic neuritis
* Acute myelitis, plus two out of three supportive criteria (as Aquaporin 4 antibody (AQP4) is often not available acutely, only the first two supportive criteria would be applied),
* Brain MRI not meeting criteria for Multiple Sclerosis (MS) at disease onset
* Spinal cord MRI with contiguous T2-weighted signal abnormality extending over three or more vertebral segments, indicating a relatively large lesion in the spinal cord
* AQP4 seropositive status
* ASIA Impairment Score of A-C
* Randomisation to occur no later than day 5 of steroids, and, if definitely known, within 21 days from symptom onset.
* Give assent (8-16 years)/consent to participate in the trial
Exclusion Criteria:
* Contraindication to IVIG as stated in the summary of product characteristics (SmPC), or receiving IVIG for other reasons
* P…
What they're measuring
1
2 points or greater improvement on the American Spinal Injury Association (ASIA) Impairment scale (classified A-E)