Neuromyelitis OpticaMultiPLEXNCT01500681
Maintenance Plasma Exchange for Neuromyelitis Optica
An observational study of Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder, run by Mayo Clinic at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis
- What is being tested?
- Plasma exchange (PLEX)
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to 9 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neuromyelitis optica/CNS demyelinating disease specialty clinics
Who may be able to join
- Neuromyelitis optica
- Neuromyelitis optica spectrum disorder
- Recurrent idiopathic longitudinally extensive myelitis
- Age 18 years or greater
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic
Scottsdale, Arizona, 85259
About this study
Official title: A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)
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.
Read the 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.
- Conditions
- Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis
- Being tested
- Plasma exchange (PLEX)
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma exchange (PLEX)Procedure or surgery
Regular maintenance PLEX courses, typically 3 procedures monthly
| Study group | Role | What they receive |
|---|---|---|
| Maintenance PLEX | Not described Receives: Procedure: Plasma exchange (PLEX) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete planned maintenance PLEX regimen
Measured: One year
Number of participants with adverse events
Measured: One year
Annualized clinical relapse rate
Measured: One year
Secondary outcomes (1)
Median Expanded Disability Status Score (EDSS)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startJun 2012
- Primary completion9 Jul 2015
- Study completion9 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis OpticaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Terumo BCT
- Responsible party
- Principal investigator, Dean Wingerchuk, Mayo Clinic
- Investigators
- Dean M Wingerchuk, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500681
- Sponsor's protocol ID
- 10-007339
- Other IDs
- MultiPLEX-2012
- Acronym
- MultiPLEX
- Status last verified
- Dec 2021
- First submitted
- 23 Dec 2011
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Maintenance Plasma Exchange (PLEX) for Neuromyelitis Optica Spectrum Disorders (MultiPLEX Study)
- ClinicalTrials.gov ID
- NCT01500681
- Acronym / sponsor ID
- MultiPLEX / 10-007339
- Conditions
- Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder, Recurrent Idiopathic Longitudinally Extensive Transverse Myelitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Terumo BCT
- Study start
- Jun 2012
- Primary completion
- 9 Jul 2015 (actual)
- Study completion
- 9 Jul 2015 (actual)
- First posted
- 28 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance PLEX | – | Procedure: Plasma exchange (PLEX) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neuromyelitis optica/CNS demyelinating disease specialty clinics
Key inclusion criteria (4 listed)
- Neuromyelitis optica
- Neuromyelitis optica spectrum disorder
- Recurrent idiopathic longitudinally extensive myelitis
- Age 18 years or greater
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma exchange (PLEX)Regular maintenance PLEX courses, typically 3 procedures monthly | Procedure or surgery | Maintenance PLEX |
Primary outcome
Number of participants who complete planned maintenance PLEX regimen
Time frame: One year
Number of participants with adverse events
Time frame: One year
Annualized clinical relapse rate
Time frame: One year
1 secondary outcome
Median Expanded Disability Status Score (EDSS)
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean M Wingerchuk, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who complete planned maintenance PLEX regimen (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.