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Maintenance Plasma Exchange for Neuromyelitis Optica (MultiPLEX)

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ClinicalTrials.gov Identifier: NCT01500681
Recruitment Status : Active, not recruiting
First Posted : December 28, 2011
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
Terumo BCT
Information provided by (Responsible Party):
Dean Wingerchuk, Mayo Clinic

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)
Study Start Date : June 2012
Estimated Primary Completion Date : August 2017

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U.S. FDA Resources

Groups and Cohorts
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Group/Cohort Intervention/treatment
Maintenance PLEX Procedure: Plasma exchange (PLEX)
Regular maintenance PLEX courses, typically 3 procedures monthly


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: December 28, 2011    Key Record Dates
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