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A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)


N/A
18 Years
N/A
Open (Enrolling)
Both
Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis

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Trial Information

A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Number of participants who complete planned maintenance PLEX regimen

Outcome Time Frame:

One year

Safety Issue:

No

Principal Investigator

Dean M Wingerchuk, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

10-007339

NCT ID:

NCT01500681

Start Date:

June 2012

Completion Date:

Related Keywords:

  • Neuromyelitis Optica
  • Neuromyelitis Optica Spectrum Disorder
  • Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis
  • Myelitis
  • Myelitis, Transverse
  • Neuromyelitis Optica

Name

Location
Mayo Clinic Rochester, Minnesota  55905
Mayo Clinic Scottsdale, Arizona