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TIMELY-PLEX Study for Optic Neuritis and Transverse Myelitis

This study, called TIMELY-PLEX, is looking at the best way to treat severe Optic Neuritis (inflammation of the optic nerve affecting vision) and severe Transverse Myelitis (inflammation of the spinal cord affecting movement and sensation). Researchers want to see if starting plasma exchange (PLEX) treatment early, alongside high-dose corticosteroids (HDCS) like methylprednisolone, leads to better vision or less disability compared to only using HDCS first and then PLEX as a rescue treatment. The study plans to enroll 382 adults aged 18 and older who have these conditions. Success will be measured by changes in vision and disability levels after 6 months. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 382 participants. It compares two treatment approaches: high-dose corticosteroids alone versus high-dose corticosteroids combined with plasma exchange.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months to assess visual acuity and disability scores.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07100990

Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Mayo Clinic
~382 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:High-dose corticosteroids (HDCS)High-dose corticosteroids (HDCS) and PLEX

At a glance

Recruiting sites
29 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
High contrast visual acuity
Measured over 6 months
+1 more outcome measured

Conditions

Optic Neuritis
Myelitis
Myelitis, Transverse

Explore related trials

Optic NeuritisTransverse myelopathy syndrome

Where it's being run

33 sites across 23 states
New York4
Maryland3
California2
Florida2
Illinois2
Massachusetts2
North Carolina2
Arizona1

Study leadership

  • John Chen · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Dean Wingerchuk, MD
[email protected]
480-684-3127
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥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
≥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

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)
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)

What this trial measures

  • High contrast visual acuity6 months

    The Optic Neuritis subjects will have high contrast visual acuity measured by ETDRS 100% high-contrast Sloan letter charts. A high contrast visual acuity of 20/20 is considered "normal," a high contrast visual acuity of 20/40 or better is required to be able to drive without restrictions, and a high contrast visual acuity of 20/200 or worse is considered legally blind.

  • Expanded Disability Status Score (EDSS)6 months

    The level of disability in Transverse Myelitis subjects will be assessed using the Expanded Disability Status Scale (EDSS). The EDSS assesses various neurological functional systems, including pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, and cereberal functions and ranges from 0 (normal neurological examination) to 10 (death). Higher scores indicate greater disability. Visual and cerebral functional system scores will be excluded from the EDSS calculation for quantification of Transverse Myelitis-related disability.