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OpenTrials
Completed

NCT Number: NCT01500681

Maintenance Plasma Exchange for Neuromyelitis Optica

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.

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Key information

Conditions

Neuromyelitis Optica Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Spectrum Disorder Optic Nerve Diseases Optic Neuritis Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic, Scottsdale, Arizona, United States

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About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma exchange (PLEX)

Procedure

Regular maintenance PLEX courses, typically 3 procedures monthly

Primary outcomes

  1. Number of participants who complete planned maintenance PLEX regimen

    Time frame: One year

  2. Number of participants with adverse events

    Time frame: One year

  3. Annualized clinical relapse rate

    Time frame: One year

Secondary outcomes

  1. Median Expanded Disability Status Score (EDSS)

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Terumo BCT

Registry information

Official study title

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

Acronym: MultiPLEX

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 28, 2011
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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