Maintenance Plasma Exchange for Neuromyelitis Optica

Completed

• Conditions: Neuromyelitis Optica; Neuromyelitis Optica Spectrum Disorder; Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis
• Interventions: Procedure: Plasma exchange (PLEX)

• Registration Number: NCT01500681
• Lead Sponsor: Mayo Clinic

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.

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 Timeline

• Study First Submitted: 2011-12-23
• Study First Submitted QC: 2011-12-23
• Study First Posted: 2011-12-28
• Study Start: 2012-06
• Primary Completion: 2015-07-09
• Study Completion: 2015-07-09
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Neuromyelitis optica
• Neuromyelitis optica spectrum disorder
• Recurrent idiopathic longitudinally extensive myelitis
• Age 18 years or greater

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Maintenance PLEX	Plasma exchange (PLEX)	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Median Expanded Disability Status Score (EDSS)	One year

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States