Text Size

Maintenance Plasma Exchange for Neuromyelitis Optica (MultiPLEX)

This study is currently recruiting participants.
Verified April 2013 by Mayo Clinic
Sponsor:
Collaborator:
Terumo BCT
Information provided by (Responsible Party):
Dean Wingerchuk, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01500681
First received: December 23, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  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:

U.S. FDA Resources

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: June 2015 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01500681

Contacts
Contact: Dean M Wingerchuk, MD 480-301-6710 wingerchuk.dean@mayo.edu

Locations
United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Dean Wingerchuk, MD     480-301-6710     wingerchuk.dean@mayo.edu    
Principal Investigator: Dean Wingerchuk, MD            
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mark Keegan, MD         keegan.bmark@mayo.edu    
Principal Investigator: Mark Keegan, MD            
Sponsors and Collaborators
Mayo Clinic
Terumo BCT
Investigators
Principal Investigator: Dean M Wingerchuk, MD Mayo Clinic
  More Information

No publications provided

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: April 22, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013