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MultiPLEX: Maintenance Plasma Exchange for Neuromyelitis Optica

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT01500681
Collaborator
Terumo BCT (Industry)
9
Enrollment
2
Locations
37.2
Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • 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

Study Type:
Observational
Actual Enrollment :
9 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 :
Jun 1, 2012
Actual Primary Completion Date :
Jul 9, 2015
Actual Study Completion Date :
Jul 9, 2015

Arms and Interventions

Arm Intervention/Treatment
Maintenance PLEX

Procedure: Plasma exchange (PLEX)
Regular maintenance PLEX courses, typically 3 procedures monthly

Outcome Measures

Primary Outcome Measures

  1. Number of participants who complete planned maintenance PLEX regimen [One year]

  2. Number of participants with adverse events [One year]

  3. Annualized clinical relapse rate [One year]

Secondary Outcome Measures

  1. Median Expanded Disability Status Score (EDSS) [One year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Mayo Clinic Scottsdale Arizona United States 85259
2 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic
  • Terumo BCT

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Dean Wingerchuk, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01500681
Other Study ID Numbers:
  • 10-007339
  • MultiPLEX-2012
First Posted:
Dec 28, 2011
Last Update Posted:
Dec 27, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Myelitis
Myelitis, Transverse
Neuromyelitis Optica

Study Results

No Results Posted as of Dec 27, 2021