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Maintenance Plasma Exchange for Neuromyelitis Optica

NCT ID: NCT01500681

Last Updated: 2021-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-07-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Maintenance PLEX

Plasma exchange (PLEX)

Intervention Type PROCEDURE

Regular maintenance PLEX courses, typically 3 procedures monthly

Interventions

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Plasma exchange (PLEX)

Regular maintenance PLEX courses, typically 3 procedures monthly

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Terumo BCT

INDUSTRY

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Dean Wingerchuk

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dean M Wingerchuk, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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MultiPLEX-2012

Identifier Type: -

Identifier Source: secondary_id

10-007339

Identifier Type: -

Identifier Source: org_study_id