Overview

This trial is active, not recruiting.

Conditions neuromyelitis optica, neuromyelitis optica spectrum disorder, recurrent idiopathic longitudinally extensive transverse myelitis
Treatment plasma exchange (plex)
Sponsor Mayo Clinic
Collaborator Terumo BCT
Start date June 2012
End date August 2016
Trial size 14 participants
Trial identifier NCT01500681, 10-007339, MultiPLEX-2012

Summary

Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance PLEX) is sometimes used to prevent relapses. This observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX for NMO.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
plasma exchange (plex)
Regular maintenance PLEX courses, typically 3 procedures monthly

Primary Outcomes

Measure
Number of participants who complete planned maintenance PLEX regimen
time frame: One year
Number of participants with adverse events
time frame: One year
Annualized clinical relapse rate
time frame: One year

Secondary Outcomes

Measure
Median Expanded Disability Status Score (EDSS)
time frame: One year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Neuromyelitis optica - Neuromyelitis optica spectrum disorder - Recurrent idiopathic longitudinally extensive myelitis - Age 18 years or greater Exclusion Criteria: - Any condition that in the opinion of the investigator could increase a participant's risk by participating in the observational study or confound the outcome of the study

Additional Information

Official title A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)
Principal investigator Dean M Wingerchuk, MD
Description Neuromyelitis optica (NMO) is an inflammatory disease of the central nervous system that is associated with autoantibodies to aquaporin-4. Treatment options for prevention of clinical relapses of NMO include immunosuppressive medications. Plasma exchange (PLEX) is commonly used as a rescue therapy for NMO relapses but ongoing, regular PLEX procedures (maintenance PLEX) is sometimes used to prevent relapses. This observational registry will record feasibility, tolerability, safety, and preliminary efficacy data regarding maintenance PLEX for participants with NMO, NMO spectrum disorders, and recurrent idiopathic longitudinally extensive transverse myelitis.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.