Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis
Conditions
Brief 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.
Detailed 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.
Interventions
PROCEDUREPlasma exchange (PLEX)
Regular maintenance PLEX courses, typically 3 procedures monthly
Sponsors
Terumo BCT
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized clinical relapse rate | One year |
| Number of participants who complete planned maintenance PLEX regimen | One year |
| Number of participants with adverse events | One year |
Secondary
| Measure | Time frame |
|---|---|
| Median Expanded Disability Status Score (EDSS) | One year |
Countries
United States
Outcome results
None listed