Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02398994
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Study:
NCT02398994
Study Brief:
Protocol Section:
NCT02398994