Phase 3 Transverse Myelitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Optic Neuritis Sub-Trial (for people with sudden vision loss due to optic nerve inflammation)

Who might be able to join this trial:

• People aged 18 or older
• People whose MRI scan shows new inflammation or swelling of one or both optic nerves, consistent with a diagnosis of optic neuritis
• People whose vision in the affected eye is severely reduced (20/200 or worse, meaning very limited sight)
• People who are within 8 days of when their vision symptoms first started
• People who are able to start a plasma exchange procedure (a blood-filtering treatment) within 72 hours of receiving the first dose of high-dose steroid treatment, if assigned to the early treatment group
• People who are able to sign and date a consent form
• People who are willing and available to follow all study procedures for the full duration of the trial

Who may not be able to join:

• People who have had a previous episode of optic neuritis in the same eye, either by their own account or confirmed by an eye specialist
• People who have an existing eye condition that significantly affects their vision or visual fields
• People who are pregnant
• People who have a medical reason they cannot safely receive high-dose steroid treatment or plasma exchange, such as unstable blood pressure, serious bleeding problems, or active serious infection (sepsis)
• People who have any other medical condition that, in the trial doctors' judgement, could interfere with participation, increase risk, or make results harder to interpret — including other neurological conditions or serious health problems
• People who have received any other experimental (investigational) treatment within 6 months before the trial starts, or within five half-lives of that treatment, whichever is longer
• People who have recently taken certain immune-suppressing or immune-modifying medications, including: mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab, or ravulizumab within the past 3 months
• People who have received certain immune cell-targeting treatments (rituximab, ocrelizumab, ofatumumab, ublituximab, or inebilizumab) within the past 6 months
• People who have received intravenous or subcutaneous immunoglobulin therapy within the past 3 months
• People who have had plasma exchange within the past 3 months
• People who have taken interferon-beta, glatiramer acetate, or certain fumarate medications within the past month
• People who have taken teriflunomide at any point in the past 24 months
• People who have taken systemic (oral or intravenous) corticosteroids within the past month (inhaled or topical steroids are not affected by this criterion)
• People who have ever been treated with alemtuzumab, cladribine, mitoxantrone, or cyclophosphamide at any time
• People who have taken any other immune-suppressing or immune-modifying medication not listed above within the past 6 months, or within five half-lives of that medication, whichever is longer

Transverse Myelitis Sub-Trial (for people with sudden spinal cord inflammation)

Who might be able to join this trial:

• People aged 18 or older
• People diagnosed with transverse myelitis, meaning they have developed sensory, movement, and/or bladder/bowel problems caused by spinal cord dysfunction; their symptoms worsened over more than 12 hours; a scan has ruled out physical compression of the spinal cord from outside; and an MRI shows inflammation within the spinal cord itself
• People who score 3.0 or higher on a standard neurological disability scale (EDSS), not counting vision or thinking-related symptoms
• People who score 2 or higher on the movement (pyramidal) portion of that same disability scale
• People who are within 8 days of when their movement symptoms first started
• People who are able to start a plasma exchange procedure within 48 hours of receiving the first dose of high-dose steroid treatment, if assigned to the early treatment group
• People who are able to sign and date a consent form
• People who are willing and available to follow all study procedures for the full duration of the trial

Who may not be able to join:

• People who already had existing problems with walking, movement, sensation, or bladder/bowel function before this episode, regardless of the cause, if those problems could make trial results harder to assess
• People whose symptoms meet possible, probable, or definite criteria for a spinal cord stroke (spinal cord infarction) rather than inflammation (confirm with trial site)
• People who have previously had radiation treatment to the spine
• People who are pregnant
• People where there is strong reason to suspect their spinal cord inflammation is caused by an infection — for example, if they have a fever, rash, or other signs of infection
• People who have a medical reason they cannot safely receive high-dose steroid treatment or plasma exchange, such as unstable blood pressure, serious bleeding problems, or active serious infection (sepsis)
• People who have any other medical condition that, in the trial doctors' judgement, could interfere with participation, increase risk, or make results harder to interpret — including other neurological conditions or serious health problems
• People who have received any other experimental (investigational) treatment within 24 weeks before the trial starts, or within five half-lives of that treatment, whichever is longer
• People who have recently taken certain immune-suppressing or immune-modifying medications, including: mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab, or ravulizumab within the past 3 months
• People who have received certain immune cell-targeting treatments (rituximab, ocrelizumab, ofatumumab, ublituximab, or inebilizumab) within the past 6 months
• People who have received intravenous or subcutaneous immunoglobulin therapy within the past 3 months
• People who have had plasma exchange within the past 3 months
• People who have taken interferon-beta, glatiramer acetate, or certain fumarate medications within the past month
• People who have taken teriflunomide at any point in the past 24 months
• People who have taken systemic (oral or intravenous) corticosteroids within the past month (inhaled or topical steroids are not affected by this criterion)
• People who have ever been treated with alemtuzumab, cladribine, mitoxantrone, or cyclophosphamide at any time
• People who have taken any other immune-suppressing or immune-modifying medication not listed above within the past 6 months, or within five half-lives of that medication, whichever is longer

Important: Always verify eligibility with the trial site directly before applying.