Maintenance Plasma Exchange for Neuromyelitis Optica (MultiPLEX)

December 7, 2021 updated by: Dean Wingerchuk, Mayo Clinic

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 NMO.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neuromyelitis optica/CNS demyelinating disease specialty clinics

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants who complete planned maintenance PLEX regimen
Time Frame: One year
One year
Number of participants with adverse events
Time Frame: One year
One year
Annualized clinical relapse rate
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Median Expanded Disability Status Score (EDSS)
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Terumo BCT

Investigators

  • Principal Investigator: Dean M Wingerchuk, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

July 9, 2015

Study Completion (Actual)

July 9, 2015

Study Registration Dates

First Submitted

December 23, 2011

First Submitted That Met QC Criteria

December 23, 2011

First Posted (Estimate)

December 28, 2011

Study Record Updates

Last Update Posted (Actual)

December 27, 2021

Last Update Submitted That Met QC Criteria

December 7, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-007339
  • MultiPLEX-2012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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