Actively Recruiting
Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX) Randomized Trial
Led by Mayo Clinic · Updated on 2026-05-05
382
Participants Needed
31
Research Sites
108 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
P
Patient-Centered Outcomes Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether starting Therapeutic Plasma Exchange (PLEX) treatment early compared to using it as a rescue treatment leads to better vision and neurological outcomes in adults with severe Optic Neuritis or severe Transverse Myelitis. This Phase 3 trial focuses on these inflammatory conditions that affect the eyes and spinal cord, aiming to find the best timing for PLEX therapy to improve patient health. Adult participants who develop severe Optic Neuritis with vision of 20/200 or worse, or severe Transverse Myelitis with significant disability, and who present within 8 days of symptom onset, are randomly assigned to one of two treatment approaches. One group receives high-dose corticosteroids (HDCS) first and adds PLEX if needed (rescue PLEX), while the other group begins both HDCS and PLEX together early. The PLEX procedure consists of 5 sessions over 5 to 10 days, exchanging 1 to 1.5 plasma volumes each session. Participants will be followed for at least 6 months, during which vision tests such as high and low contrast acuity, color vision plates, and retinal imaging will be done, along with neurological disability assessments like the Expanded Disability Status Scale (EDSS). Additional evaluations include quality of life questionnaires and monitoring for PLEX complications up to one month. This study helps measure the effects of early versus rescue PLEX treatment on vision and neurological function over time.
CONDITIONS
Brief Title
Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- For Optic Neuritis sub-trial: MRI showing new optic nerve inflammation and visual acuity of 20/200 or worse
- For Optic Neuritis: symptom onset within 8 days and ability to start plasma exchange within 72 hours of corticosteroids if randomized to early PLEX
- For Transverse Myelitis sub-trial: diagnosis based on sensory, motor, or autonomic spinal cord symptoms with MRI evidence of inflammation
- For Transverse Myelitis: Expanded Disability Status Scale (EDSS) score 3.0 or higher and symptom onset within 8 days
- Ability to give informed consent and comply with study procedures
- Willingness to remain available for the study duration
You will not qualify if you...
- Prior episode of optic neuritis in the affected eye
- Eye conditions significantly affecting vision or visual fields
- Pregnancy
- Contraindications to corticosteroids or plasma exchange such as unstable blood pressure, bleeding problems, or infection
- Medical conditions that interfere with participation or risk assessment, including other neurological diseases
- Use of investigational drugs within 6 months before study
- Recent or ongoing immune-modulating or immunosuppressive treatments, including specific drugs within defined timeframes
- Pre-existing disabilities affecting motor, sensory, or bowel/bladder function that could affect trial assessments
- Spinal cord infarction diagnosis or previous radiation to the spine
- Suspicion of infectious cause for myelitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 3 weeks depending on treatment response
Participants receive initial treatment with high-dose corticosteroids for 5 days. Depending on their response, plasma exchange (PLEX) may be given either concurrently or as a rescue therapy within 7 to 14 days. PLEX involves 5 sessions over 5 to 10 days.
Multiple visits over 5 to 10 days for PLEX sessions plus treatment visits for corticosteroids
Duration - 6 months
Participants are monitored for outcomes and potential complications for up to 6 months after treatment.
Visits at 2 weeks, 1 month, and at 6 months post-treatment
Trial Site Locations
Total: 31 locations
1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Actively Recruiting
2
University of California, Davis
Sacramento, California, United States, 95817
Active, Not Recruiting
3
University of Colorado - Anschutz Medical
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Yale University School of Medicine
North Haven, Connecticut, United States, 06510
Actively Recruiting
5
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Active, Not Recruiting
6
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
7
University of Illinois Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
8
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
9
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
10
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201
Actively Recruiting
11
Johns Hopkins University
Baltimore, Maryland, United States, 21218
Actively Recruiting
12
Medstar Health Research Institute
Columbia, Maryland, United States, 21044
Actively Recruiting
13
Harvard University Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
14
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
15
Regents of the University of Michigan
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
16
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
17
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
18
NYU Langone Health
New York, New York, United States, 10016
Active, Not Recruiting
19
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
20
Columbia University
New York, New York, United States, 10032
Actively Recruiting
21
Weill Cornell Medical College
New York, New York, United States, 10065
Actively Recruiting
22
Duke University Health System
Durham, North Carolina, United States, 27710
Actively Recruiting
23
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Active, Not Recruiting
24
Dean McGee Eye Institute at University of Oklahoma Health Sciences
Oklahoma City, Oklahoma, United States, 73117
Active, Not Recruiting
25
Oregon Health & Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
26
University of Pittsburgh Medical Center, Magee Hospital
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
27
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
28
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
29
University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
30
University of Virginia
Charlottesville, Virginia, United States, 22908
Active, Not Recruiting
31
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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