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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 8 August 2016
Main ID:  NCT02398994
Date of registration: 23/03/2015
Prospective Registration: Yes
Primary sponsor: Guy's and St Thomas' NHS Foundation Trust
Public title: A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis STRIVE
Scientific title: A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin (IVIg) Versus Standard Therapy for the Treatment of Transverse Myelitis in Adults and Children
Date of first enrolment: March 2015
Target sample size: 2
Recruitment status: Terminated
URL:  https://clinicaltrials.gov/show/NCT02398994
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
United Kingdom
Contacts
Name:     Ming Lim, MB, PhD
Address: 
Telephone:
Email:
Affiliation:  Guy's and St Thomas' NHS Foundation Trust
Key inclusion & exclusion criteria

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

- Previously known systemic autoimmune disease (e.g. systemic lupus erythematosus) or
any evidence of systemic inflammation during current presentation.

- Direct infectious aetiology (e.g. varicella zoster)

- Previous episode of central nervous system (CNS) inflammatory demyelination

- Acute disseminated encephalomyelitis (ADEM)

- Other causes of myelopathy not thought to be due to myelitis (e.g. nutritional,
ischaemic, tumour etc.)

- Other disease which would interfere with assessment of outcome measures

- Known pregnancy

- Circumstances which would prevent follow-up for 12 month



Age minimum: 1 Year
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Myelitis, Transverse
Neuromyelitis Optica
Intervention(s)
Drug: Intravenous Immunoglobulin
Drug: Intravenous Methylprednisolone
Primary Outcome(s)
2 points or greater improvement on the American Spinal Injury Association (ASIA) Impairment scale (classified A-E) [Time Frame: 6 months]
Secondary Outcome(s)
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]
Client Service Receipt Inventory (CSRI) [Time Frame: 6 months]
EQ-5D-5L (for patients aged 13 years or over at presentation) [Time Frame: 6 months]
EQ-5D-Y (for patients aged 8-12 years 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]
Secondary ID(s)
11/129/148
12127581
2014-002335-34
RJ115/N065
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Alder Hey Children's NHS Foundation Trust
Barts & The London NHS Trust
Barts and the London School of Medicine and Dentistry
Birmingham Children's Hospital NHS Foundation Trust
Cardiff and Vale University Health Board
Cardiff University
Central Manchester University Hospitals NHS Foundation Trust
Great Ormond Street Hospital for Children NHS Foundation Trust
King's College Hospital NHS Trust
King's College London
Newcastle-upon-Tyne Hospitals NHS Trust
NHS Lothian
North Bristol NHS Trust
Nottingham University Hospitals NHS Trust
Oxford University Hospitals NHS Trust
Salford Royal NHS Foundation Trust
University College, London
University Hospital Birmingham NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust.
University Hospitals Bristol NHS Foundation Trust
Walton Centre NHS Foundation Trust
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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