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NCT07100990 · ClinicalTrials.gov registry record · Phase 3
Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
A Phase 3 study of Optic Neuritis and Myelitis, Transverse, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 382
- Enrollment target
- 20
- Study locations
NCT07100990: Recruiting Phase 3 study of Optic Neuritis and Myelitis, Transverse, sponsored by Mayo Clinic.
NCT07100990 is a Phase 3 study of Optic Neuritis and Myelitis, Transverse that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 382 participants, below the 728-participant average among 5 other Optic Neuritis trials with a reported enrollment target (48% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07100990, a Phase 3 study of Optic Neuritis and Myelitis, Transverse, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 382 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG High-dose corticosteroids (HDCS)
- DRUG High-dose corticosteroids (HDCS) and PLEX
Study Locations (20)
Illinois
- University of Illinois Chicago - Chicago
- Northwestern University - Evanston
Maryland
- University of Maryland, Baltimore - Baltimore
- Johns Hopkins University - Baltimore
Massachusetts
- Harvard University Massachusetts General Hospital - Boston
- Boston Medical Center - Boston
New York
- Icahn School of Medicine at Mount Sinai - New York
- Weill Cornell Medical College - New York
Arizona
- Mayo Clinic Arizona - Scottsdale
Colorado
- University of Colorado - Anschutz Medical - Aurora
Connecticut
- Yale University School of Medicine - North Haven
Florida
- Mayo Clinic Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 382 participants |
| Start Date | 2025-07-11 |
| Est. Completion | 2031-04-30 |
| Phase | Phase 3 |
What NCT07100990 shows while recruiting
NCT07100990 is an interventional study that assigns participants to a tested intervention. The registered 382 participants enrollment target is mid-sized for trials with a published cap, below the 728-participant average among 5 other Optic Neuritis trials with a reported enrollment target (48% lower).
The record links to 3 conditions, with Optic Neuritis appearing as the primary indexed condition, and to 2 interventions - of which High-dose corticosteroids (HDCS) is the first listed.
NCT07100990 names 20 study sites across 16 states, led by Illinois, Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07100990 about?
NCT07100990 is a clinical study titled "Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)". 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.
What is the current status of trial NCT07100990?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 382 participants. The study started on 2025-07-11. Estimated completion is 2031-04-30.
What conditions does trial NCT07100990 study?
This clinical trial studies the following conditions: Optic Neuritis, Myelitis, Transverse, Myelitis.
What interventions are being tested in trial NCT07100990?
The interventions under investigation include: High-dose corticosteroids (HDCS) (DRUG), High-dose corticosteroids (HDCS) and PLEX (DRUG).
Who is sponsoring clinical trial NCT07100990?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07100990 being conducted?
This trial has 20 study locations across Arizona, Colorado, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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