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NCT01500681 Clinical Trial

Maintenance Plasma Exchange for Neuromyelitis Optica

Neuromyelitis Optica Clinical Trial

— MultiPLEX  

Official title:
A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01500681
Other study ID # 10-007339
Secondary ID MultiPLEX-2012
Status Completed
Phase
First received
Last updated
Start date June 2012
Est. completion date July 9, 2015

Study information
Verified date December 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date July 9, 2015
Est. primary completion date July 9, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota
United States Mayo Clinic Scottsdale Arizona

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Terumo BCT

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants who complete planned maintenance PLEX regimen One year
Primary Number of participants with adverse events One year
Primary Annualized clinical relapse rate One year
Secondary Median Expanded Disability Status Score (EDSS) One year
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Terminated NCT02398994 - A Multicentre randomiSed Controlled TRial of IntraVEnous Immunoglobulin Versus Standard Therapy for Transverse Myelitis Phase 3
Withdrawn NCT02087813 - Pilot Study of alpha1-antitrypsin to Treat Neuromyelitis Optica Relapses Phase 1
Terminated NCT01339455 - Autologous Hematopoietic Stem Cell Transplant in Neuromyelitis Optica Phase 1/Phase 2
Recruiting NCT02021825 - Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders Phase 4
Active, not recruiting NCT04614454 - High Frequency Impulse Therapy for Neuropathic Pain in NMOSD Phase 2
Recruiting NCT03370965 - Optic Neuritis Differential Diagnosis Study N/A
Completed NCT01777412 - Efficacy of Bevacizumab (Avastin) in Treatment of Acute NMO Exacerbations Phase 1

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