Actively Recruiting
Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
Led by Mayo Clinic · Updated on 2026-05-05
382
Participants Needed
31
Research Sites
302 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
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.
CONDITIONS
Official 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: MRI showing new optic nerve inflammation, visual acuity 20/200 or worse, symptoms started within 8 days, able to begin plasma exchange within 72 hours if assigned early treatment, able to consent and follow study procedures
- For Transverse Myelitis: Diagnosis based on clinical symptoms and MRI showing spinal cord inflammation, Expanded Disability Status Scale (EDSS) of 3.0 or higher excluding visual and cerebral systems, pyramidal function score of 2 or higher, symptoms started within 8 days, able to begin plasma exchange within 48 hours if assigned early treatment, able to consent and follow study procedures
You will not qualify if you...
- Previous episode of optic neuritis in the affected eye
- Eye conditions affecting vision or visual fields
- Pregnancy
- Contraindications to corticosteroids or plasma exchange such as unstable blood pressure, bleeding problems, or infection
- Medical conditions that could interfere with participation or risk safety, including other neurological or medical diseases
- Recent treatment with investigational agents or certain immune-modulating or immunosuppressive therapies within specified time frames before randomization
- Pre-existing disabilities affecting mobility, sensation, or bladder/bowel function for Transverse Myelitis group
- Possible or definite spinal cord infarction diagnosis
- History of spinal radiation
- Signs of infection causing myelitis
- Prior treatment with specific immune therapies including alemtuzumab, cladribine, mitoxantrone, or cyclophosphamide
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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