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Maintenance Plasma Exchange for Neuromyelitis Optica (MultiPLEX)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01500681
First Posted: December 28, 2011
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Terumo BCT
Information provided by (Responsible Party):
Dean Wingerchuk, Mayo Clinic
  Purpose
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.

Condition Intervention
Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis Procedure: Plasma exchange (PLEX)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)

Resource links provided by NLM:


Further study details as provided by Dean Wingerchuk, Mayo Clinic:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Median Expanded Disability Status Score (EDSS) [ Time Frame: One year ]

Estimated Enrollment: 14
Study Start Date: June 2012
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Maintenance PLEX Procedure: Plasma exchange (PLEX)
Regular maintenance PLEX courses, typically 3 procedures monthly

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neuromyelitis optica/CNS demyelinating disease specialty clinics
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500681


Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Terumo BCT
Investigators
Principal Investigator: Dean M Wingerchuk, MD Mayo Clinic
  More Information

Responsible Party: Dean Wingerchuk, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01500681     History of Changes
Other Study ID Numbers: 10-007339
MultiPLEX-2012
First Submitted: December 23, 2011
First Posted: December 28, 2011
Last Update Posted: March 22, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Neuromyelitis Optica
Myelitis
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases