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

NCT07100990 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2026-05-05

No results posted yet for this 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.

Conditions

Interventions

DRUG

High-dose corticosteroids (HDCS)

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.

DRUG

High-dose corticosteroids (HDCS) and PLEX

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.

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • John Chen · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2029-04-01
Completion
2031-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07100990 on ClinicalTrials.gov