A Phase 3 interventional study of High-dose corticosteroids (HDCS) and High-dose corticosteroids (HDCS) and PLEX in Optic Neuritis, Myelitis and Myelitis, Transverse, sponsored by Mayo Clinic. Recruiting at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Mayo Clinic · Phase 3, Interventional, and Treatment
The purpose of this research is to evaluate if early vs rescue Therapeutic Plasma Exchange (PLEX) treatment algorithm leads to better visual outcomes in severe Optic Neuritis and leads to better neurological disability outcomes in severe Transverse Myelitis.
88 studies on the registry are indexed under Optic Neuritis; 16 are open to participants now.
This study's planned enrollment of 382 is above the median of 50 across 58 interventional studies indexed under Optic Neuritis.
Browse Optic Neuritis studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion criteria:
Ongoing/prior treatment with immune-modulating/ therapy including:
Transverse Myelitis Sub-Trial:
Inclusion criteria:
Diagnosis of Transverse Myelitis (defined based on modified criteria adapted from the 2002 Transverse Myelitis Consortium Working Group; ALL are required)
Exclusion criteria:
Treatment with any investigational agent within 24 weeks of baseline or five half-lives of the investigational agent (whichever is longer)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult participants presenting within 14 days of symptom onset with severe Optic Neuritis (ON) (visual acuity of 20/200 or worse
Drug: High-dose corticosteroids (HDCS)
Adult participants presenting within 14 days of symptom onset with severe Optic Neuritis (ON) (visual acuity of 20/200 or worse
Drug: High-dose corticosteroids (HDCS) and PLEX
Adult participants presenting within 14 days of symptom onset with severe Transverse Myelitis (TM) (expanded Disability Status Scale \[EDSS\] of 3.0 or worse)
Drug: High-dose corticosteroids (HDCS)
Adult participants presenting within 14 days of symptom onset with severe Transverse Myelitis (TM) (expanded Disability Status Scale \[EDSS\] of 3.0 or worse)
Drug: High-dose corticosteroids (HDCS) and PLEX
Subjects will receive initial treatment with high-dose corticosteroids (HDCS) in the form of methylprednisolone (1,000mg daily) administered intravenously for 5 days or a bioequivalent dose of oral corticosteroids (e.g., 1,250mg prednisone daily or 176mg dexamethasone daily). Subjects will be escalated to PLEX if there is an insufficient response to HDCS (decision point at 14±2 days for the ON sub-trial and 7±1 days for the TM sub-trial) PLEX will be performed as 5 sessions over 5-10 days, with 1-1.5 plasma volumes exchanged per session.
Also known as: Rescue Plex
Subjects will receive treatment with high-dose corticosteroids (HDCS) and PLEX initiated concurrently. HDCS will be administered in the form of methylprednisolone (1,000mg daily) administered intravenously for 5 days or a bioequivalent dose of oral corticosteroids (e.g., 1,250mg prednisone daily or 176mg dexamethasone daily). PLEX will be performed as 5 sessions over 5-10 days, with 1-1.5 plasma volumes exchanged per session.
Also known as: Early Plex
High contrast visual acuity
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.
Time frame: 6 months
Expanded Disability Status Score (EDSS)
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.
Time frame: 6 months
Low contrast (2.5%) visual acuity
Optic Neuritis subjects will have low contrast visual acuity (best corrected) assessed with 2.5% low-contrast Sloan letter charts
Time frame: 6 months
Peri-papillary retinal nerve fiber layer (RNFL thickness)
Optic Neuritis subjects will have RNFL thickness measured via Retinal Optical Coherence Tomography (OCT).
Time frame: 6 months
Macular ganglion cell-inner plexiform layer (GCIPL) thicknesses
Optic Neuritis subjects will have GCIPL thickness measured via Retinal Optical Coherence Tomography (OCT).
Time frame: 6 months
Hardy Rand and Rittler (HRR) color plates
The Hardy-Rand-Rittler (HRR) color plates test will be administered to Optic Neuritis subjects. The HRR is scored based on the number of correct responses to the diagnostic plates, with the total number of correct figures out of 28 being the primary score.
Time frame: 6 months
National Eye Institute (NEI) 10-Item Neuro-Ophthalmic Supplement
Optic Neuritis subjects will complete the 10-Item Neuro-Ophthalmic Supplement, a 10-item questionnaire used to assess visual dysfunction in patients with neuro-ophthalmologic disorders. It is scored on a scale of 0 to 100, with higher scores indicating better visual functioning.
Time frame: 6 months
Ambulatory disability
Transverse Myelitis subjects will be assessed for ambulatory disability using the Hauser Ambulation Index, a timed 25 foot, 6 minute walk.
Time frame: 6 months
Manual dexterity (Nine-Hole Peg Test)
The Nine-Hole Peg Test will be administered to the Transverse Myelitis subjects. Subjects will be asked to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. They will then remove the pegs, one by one, from the board as quickly as possible. Scores are based on the time taken to complete the activity and are reported in seconds.
Time frame: 6 months
Patient Determined Disease Steps (PDDS)
Transverse Myelitis subjects will complete the Patient-Determined Disease Steps (PDDS), a self-reported disability scale with 9 levels ranging from no disability to bedridden.
Time frame: 6 months
Spinal Cord Injury Quality of Life questionnaire (SCI-QoL)
Transverse Myelitis subjects will complete the The Spinal Cord Injury Quality of Life questionnaire (SCI-QoL), which includes assessments of specific domains related to bladder/bowel dysfunction, pain, pressure ulcers, mobility/ambulation, fine motor skills, self-care, and wheelchair mobility.
Time frame: 6 months
PLEX Complications
Total number of adverse events categorized according to the Common Terminology Criteria for Adverse Events v5.0
Time frame: 2 weeks, 1 month
National Eye Institute (NEI) Visual Function Questionnaire (VFQ)-25
Optic Neuritis subjects will complete the National Eye Institute Visual Functioning Questionnaire-25. The questionnaire consists of 25 items, covering 11 vision-related domains, plus a single global-rating item. Items are scored and converted to a 0- to 100-point scale where higher scores indicate better functioning.
Time frame: 6 months
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: No
Started Jul 2025 (actual). Primary completion is estimated for Apr 2029, 44 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.