Clinical Trial: Maintenance Plasma Exchange for Neuromyelitis Optica

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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

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 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 participants with NMO, NMO spectrum disorders, and recurrent idiopathic longitudinally extensive transverse myelitis.
Sponsor: Mayo Clinic

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome: Median Expanded Disability Status Score (EDSS) [ Time Frame: One year ]

Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: December 23, 2011
Date Started: June 2012
Date Completion:
Last Updated: March 21, 2017
Last Verified: March 2017