Maintenance Plasma Exchange for Neuromyelitis Optica
MultiPLEX
A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)
2 other identifiers
observational
9
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jun 2012
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2011
CompletedFirst Posted
Study publicly available on registry
December 28, 2011
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 9, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 9, 2015
CompletedDecember 27, 2021
December 1, 2021
3.1 years
December 23, 2011
December 7, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Number of participants who complete planned maintenance PLEX regimen
One year
Number of participants with adverse events
One year
Annualized clinical relapse rate
One year
Secondary Outcomes (1)
Median Expanded Disability Status Score (EDSS)
One year
Study Arms (1)
Maintenance PLEX
Interventions
Regular maintenance PLEX courses, typically 3 procedures monthly
Eligibility Criteria
Neuromyelitis optica/CNS demyelinating disease specialty clinics
You may qualify if:
- Neuromyelitis optica
- Neuromyelitis optica spectrum disorder
- Recurrent idiopathic longitudinally extensive myelitis
- Age 18 years or greater
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Terumo BCTcollaborator
Study Sites (2)
Mayo Clinic
Scottsdale, Arizona, 85259, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dean M Wingerchuk, MD
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 23, 2011
First Posted
December 28, 2011
Study Start
June 1, 2012
Primary Completion
July 9, 2015
Study Completion
July 9, 2015
Last Updated
December 27, 2021
Record last verified: 2021-12