Maintenance Plasma Exchange for Neuromyelitis Optica (MultiPLEX)
This study is ongoing, but not recruiting participants.
Sponsor:
Mayo Clinic
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
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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:
Genetics Home Reference related topics:
neuromyelitis optica
Genetic and Rare Diseases Information Center resources:
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Myelitis
Transverse Myelitis
Optic Neuritis
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: | 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
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 September 30, 2016