Treatment of Inflammatory Myelitis and Optic Neuritis With Early vs Rescue Plasma Exchange (TIMELY-PLEX)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
≥18 years of age
MRI orbits demonstrating evidence of new T2 hyperintensity and/or post-gadolinium contrast enhancement of the optic nerve(s) and meeting the clinical criteria for Optic Neuritis
Visual acuity 20/200 or worse
Within 8 days of onset of visual symptoms
Trial design
Treatments tested in this trial
- High-dose corticosteroids (HDCS)
- High-dose corticosteroids (HDCS) and PLEX
Treatment groups
382 Participants
are divided into 4 treatment groupsSponsors and collaborators
Mayo Clinic
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov