Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
TIMELY-PLEX
A Randomized Controlled, Open-Label, Rater-Blinded Pragmatic Trial, Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
1 other identifier
interventional
382
1 country
31
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2025
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 11, 2025
CompletedFirst Submitted
Initial submission to the registry
July 28, 2025
CompletedFirst Posted
Study publicly available on registry
August 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2031
May 5, 2026
April 1, 2026
3.7 years
July 28, 2025
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
6 months
Secondary Outcomes (11)
Low contrast (2.5%) visual acuity
6 months
Peri-papillary retinal nerve fiber layer (RNFL thickness)
6 months
Macular ganglion cell-inner plexiform layer (GCIPL) thicknesses
6 months
Hardy Rand and Rittler (HRR) color plates
6 months
National Eye Institute (NEI) 10-Item Neuro-Ophthalmic Supplement
6 months
- +6 more secondary outcomes
Study Arms (4)
Optic Neuritis (ON) "Rescue PLEX"
ACTIVE COMPARATORAdult participants presenting within 8 days of symptom onset with severe Optic Neuritis (ON) (visual acuity of 20/200 or worse
Optic Neuritis (ON) "Early PLEX"
EXPERIMENTALAdult participants presenting within 8 days of symptom onset with severe Optic Neuritis (ON) (visual acuity of 20/200 or worse
Transverse Myelitis "Rescue PLEX"
ACTIVE COMPARATORAdult participants presenting within 8 days of symptom onset with severe Transverse Myelitis (TM) (expanded Disability Status Scale \[EDSS\] of 3.0 or worse)
Transverse Myelitis "Early PLEX"
EXPERIMENTALAdult participants presenting within 8 days of symptom onset with severe Transverse Myelitis (TM) (expanded Disability Status Scale \[EDSS\] of 3.0 or worse)
Interventions
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±2 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.
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.
Eligibility Criteria
You may not qualify if:
- Optic Neuritis Sub-Trial:
- ≥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
- 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:
- +38 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Patient-Centered Outcomes Research Institutecollaborator
- Mayo Cliniclead
Study Sites (31)
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
University of California, Davis
Sacramento, California, 95817, United States
University of Colorado - Anschutz Medical
Aurora, Colorado, 80045, United States
Yale University School of Medicine
North Haven, Connecticut, 06510, United States
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
University of Miami
Miami, Florida, 33136, United States
University of Illinois Chicago
Chicago, Illinois, 60612, United States
Northwestern University
Evanston, Illinois, 60208, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21218, United States
Medstar Health Research Institute
Columbia, Maryland, 21044, United States
Harvard University Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Regents of the University of Michigan
Ann Arbor, Michigan, 48105, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
NYU Langone Health
New York, New York, 10016, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Weill Cornell Medical College
New York, New York, 10065, United States
Duke University Health System
Durham, North Carolina, 27710, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Dean McGee Eye Institute at University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73117, United States
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
University of Pittsburgh Medical Center, Magee Hospital
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Utah
Salt Lake City, Utah, 84112, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
University of Washington
Seattle, Washington, 98195, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Chen
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 28, 2025
First Posted
August 3, 2025
Study Start
July 11, 2025
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
April 30, 2031
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share