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RECRUITING Phase 3

Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)

NCT07100990 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 382 participants
Start Date 2025-07-11
Est. Completion 2031-04-30
Phase Phase 3

Sponsor

Mayo Clinic

3,246 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07100990

The ClinicalTrials.gov registry entry for NCT07100990 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 382 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 3,246 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07100990 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Illinois, Maryland, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07100990?

This trial is sponsored by Mayo Clinic, which has 3,246 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial