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Can early plasma exchange save sight and mobility?

NCT ID NCT07100990

Disease control Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests whether starting plasma exchange early, rather than waiting, leads to better vision in severe optic neuritis and less disability in severe transverse myelitis. About 382 adults with these inflammatory nerve conditions will be randomly assigned to early or rescue plasma exchange. The goal is to see if early treatment improves outcomes like visual sharpness and overall neurological function.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 382 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Study Population and Setting The proposal will recruit participants presenting to participating sites with severe ON or severe TM to two separate sub-trials. The detailed inclusion and exclusion criteria for each sub-trial are listed below: Optic Neuritis Sub-Trial: Inclusion criteria: * ≥18 years of age * MRI orbits demonstrating evidence of new T2 hyperintensity and/or post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis * Visual acuity 20/200 or worse * Within 8 days of onset of visual symptoms * Able to initiate PLEX within 72h of the first dose of HDCS (if randomized to the "Early PLEX" treatment arm) * Able to sign and date informed consent form * Willingness to comply with all study procedures and availability for the duration of the study Exclusion criteria: * Evidence of prior episode of optic neuritis in the affected eye (by history or ophthalmological evaluation) * Ophthalmological comorbidity that would significantly affect best corrected visual acuity or visual fields * Pregnancy * Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding/coagulopathy, or sepsis. * Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and/or medical comorbidity) * Treatment with any investigational agent within 6 months of baseline or five half-lives of the investigational agent (whichever is longer) * Ongoing/prior treatment with immune-modulating/immunosuppressive therapy including: * Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization * Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization * Intravenous or subcutaneous immune globulin within 3 months of randomization * Plasma exchange within 3 months of randomization * Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization * Teriflunomide use within prior 24 months * Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization * Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide * Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer) Transverse Myelitis Sub-Trial: Inclusion criteria: * ≥18 years of age * Diagnosis of Transverse Myelitis (defined based on modified criteria adapted from the 2002 Transverse Myelitis Consortium Working Group; ALL are required) * Development of sensory, motor and/or autonomic symptomatology attributable to spinal cord dysfunction * Onset of symptoms to nadir \>12 hours * Exclusion of extra-axial compressive etiology by neuroimaging * Demonstration of inflammation within the spinal cord by presence of intramedullary T2 lesion (post-gadolinium enhancing OR non-enhancing) on MRI * Expanded Disability Status Scale \[EDSS\] ≥3.0 (excluding visual and cerebral functional systems) * EDSS Pyramidal Functional System Score ≥ 2 * Within 8 days of onset of motor symptoms * Able to initiate PLEX within 48h of the first dose of HDCS (if randomized to the "Early PLEX" treatment arm) * Able to sign and date informed consent form * Willingness to comply with all study procedures and availability for the duration of the study Exclusion criteria: * Pre-existing ambulatory, motor, sensory, or bowel/bladder disability of any cause that could confound trial assessments * Fulfillment of possible, probable or definite spinal cord infarction diagnosis per proposed diagnostic criteria (Zalewski et al. JAMA Neurology 2018) * History of radiation to the spine * Pregnancy * High clinical suspicion for infectious etiology of myelitis (e.g., fever, rash or other findings) * Presence of any contraindication to receiving HDCS or PLEX, including, but not limited to, hemodynamic instability, significant bleeding/coagulopathy, or sepsis. * Any medical condition that, in the opinion of the investigator, may interfere with the patient's participation in the trial, pose any added risk for the patient, or confound the assessment of the patient (including but not limited to concurrent neurological disease and/or medical comorbidity) * Treatment with any investigational agent within 24 weeks of baseline or five half-lives of the investigational agent (whichever is longer) * Ongoing/prior treatment with immune-modulating/immunosuppressive therapy including: Mycophenolate mofetil, azathioprine, methotrexate, fingolimod, siponimod, ponesimod, ozanimod, tocilizumab, satralizumab, eculizumab or ravulizumab within 3 months of randomization * Anti-CD20 (rituximab, ocrelizumab, ofatumumab, ublituximab) or anti-CD19 (inebilizumab) therapy within 6 months of randomization * Intravenous or subcutaneous immune globulin within 3 months of randomization * Plasma exchange within 3 months of randomization * Interferon-beta, glatiramer acetate, fumarates (dimethyl fumarate, monomethyl fumarate, diroximel fumarate) within 1 month of randomization * Teriflunomide use within prior 24 months * Systemic corticosteroid therapy (intravenous or oral; excluding inhaled or topical corticosteroids) within 1 month of randomization * Any previous treatment with alemtuzumab, cladribine, mitoxantrone or cyclophosphamide * Previous treatment with any immune-modulating or immunosuppressive therapy not mentioned above within 6 months of randomization or five-half-lives (whichever is longer)

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Conditions

The condition(s) this trial relates to.

acute transverse myelitis myelitis optic neuritis transverse myelitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelitis Myelitis, transverse Optic neuritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    29 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Dean McGee Eye Institute at University of Oklahoma Health Sciences

    ACTIVE_NOT_RECRUITING

    Oklahoma City, Oklahoma, 73117, United States

  • Duke University Health System

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Harvard University Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • Loma Linda University

    ACTIVE_NOT_RECRUITING

    Loma Linda, California, 92350, United States

  • Mayo Clinic Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medstar Health Research Institute

    RECRUITING

    Columbia, Maryland, 21044, United States

  • NYU Langone Health

    ACTIVE_NOT_RECRUITING

    New York, New York, 10016, United States

  • Northwestern University

    RECRUITING

    Evanston, Illinois, 60208, United States

  • Oregon Health & Sciences University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Regents of the University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of California, Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Colorado - Anschutz Medical

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Illinois Chicago

    RECRUITING

    Chicago, Illinois, 60612, United States

  • University of Maryland, Baltimore

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Mississippi Medical Center

    RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of North Carolina School of Medicine

    ACTIVE_NOT_RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh Medical Center, Magee Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Weill Cornell Medical College

    RECRUITING

    New York, New York, 10065, United States

  • Yale University School of Medicine

    RECRUITING

    North Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.