Maintenance Plasma Exchange for Neuromyelitis Optica (MultiPLEX)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Terumo BCT
Information provided by (Responsible Party):
Dean Wingerchuk, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01500681
First received: December 23, 2011
Last updated: March 14, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis
Procedure: Plasma exchange (PLEX)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Number of participants who complete planned maintenance PLEX regimen [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Annualized clinical relapse rate [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median Expanded Disability Status Score (EDSS) [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 14
Study Start Date: June 2012
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Maintenance PLEX Procedure: Plasma exchange (PLEX)
Regular maintenance PLEX courses, typically 3 procedures monthly

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neuromyelitis optica/CNS demyelinating disease specialty clinics
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500681

Locations
United States, Arizona
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Terumo BCT
Investigators
Principal Investigator: Dean M Wingerchuk, MD Mayo Clinic
  More Information

Responsible Party: Dean Wingerchuk, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01500681     History of Changes
Other Study ID Numbers: 10-007339  MultiPLEX-2012 
Study First Received: December 23, 2011
Last Updated: March 14, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neuromyelitis Optica
Myelitis
Myelitis, Transverse
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 24, 2016