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
• 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
• 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

Related Conditions & MeSH terms

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

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

External Links

•   Mayo Clinic Clinical Trials