NCT02850705

Brief Summary

Devic's neuromyelitis optica (NMO) is rare. Epidemiological and demographic data are poor, based mainly on monocentric cohorts. Moreover, NMO might be difficult to distinguish from multiple sclerosis and begin with atypical or incomplete clinical presentations. Therefore, NMO is still underdiagnosed. The constitution of a nationwide and prospective cohort, including not only NMO but also clinical syndromes suggestive of a first episode (DNMO-spectrum disorders (SDs)), should allow to gather a critical mass of cases and answer questions that could not have been addressed at the level of a single centre. Objectives: The main objective is to describe the clinical, radiological and biological features of NMO spectrum disorder (NMO, isolated longitudinally extensive transverse myelitis (LETM), relapsing or not; isolated atypical optic neuritis (ON)) and their evolution. The second aim is to create a biobank dedicated to NMO (serum, whole blood for RNA and DNA extraction, cerebrospinal fluid), to promote translational research in the field. Methods: NOMADMUS is a prospective, multicentre, observational study of patients NMOSD and related disorder in France. Prevalent cases are included retrospectively and then followed prospectively. Incident cases are included from disease onset and followed prospectively. A minimal set of data has been defined and synthesized on specific paper forms derived from the European database for multiple sclerosis (EDMUS) forms. Patients are systematically tested regarding their AQP4-IgG and MOG-IgG status. All the data are centralised in a EDMUS-derived database in Lyon, the EDEN software. All cases are validated and classified by an expert committee.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,787

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 1, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

11.8 years

First QC Date

July 22, 2016

Last Update Submit

March 29, 2022

Conditions

Neuromyelitis Optica Spectrum DisordersNeuromyelitis Optica Spectrum Related Disorders

Keywords

Neuromyelitis OpticaMyelitisOptic Neuritisautoantibodydemyelination

Outcome Measures

Primary Outcomes (1)

  • number of cases of NMO or NMOSD included in the cohort

    At 5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Devic's Neuromyelitis Optica NMO

You may qualify if:

  • Definite Devic's Neuromyelitis Optica NMO according to established criteria (Wingerchuk 1999, Wingerchuk 2006, International panel 2015)
  • high risk syndromes for NMOSD, defined as: recurrent or simultaneous optic neuritis, idiopathic single or recurrent longitudinally extensive transverse myelitis (spinal cord lesion seen on MRI \>3 vertebral segments)
  • patients tested positive for AQP4-IgG autoantibody or MOG-IgG autoantibody
  • living in France since 5 years minimum

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer

Bron, 69500, France

Location

Related Publications (2)

  • Januel E, Brochard V, Le Guennec L, Maillart E, Louapre C, Lubetzki C, Weiss N, Demeret S, Papeix C. Risk factors and prognosis of orotracheal intubation in aquaporin-4-IgG neuromyelitis optica spectrum disorder attacks. Ann Intensive Care. 2024 Jan 8;14(1):4. doi: 10.1186/s13613-023-01213-x.

    PMID: 38185760DERIVED

  • Demuth S, Collongues N, Audoin B, Ayrignac X, Bourre B, Ciron J, Cohen M, Deschamps R, Durand-Dubief F, Maillart E, Papeix C, Ruet A, Zephir H, Marignier R, De Seze J; NOMADMUS Study Group. Rituximab De-escalation in Patients With Neuromyelitis Optica Spectrum Disorder. Neurology. 2023 Jul 25;101(4):e438-e450. doi: 10.1212/WNL.0000000000207443. Epub 2023 Jun 8.

    PMID: 37290967DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum, CSF, DNA, PBMC

MeSH Terms

Conditions

Neuromyelitis OpticaMyelitisOptic NeuritisDemyelinating Diseases

Condition Hierarchy (Ancestors)

Myelitis, TransverseDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesOptic Nerve DiseasesCranial Nerve DiseasesEye DiseasesAutoimmune DiseasesImmune System DiseasesCentral Nervous System InfectionsInfectionsCentral Nervous System DiseasesSpinal Cord DiseasesNeuroinflammatory Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2016

First Posted

August 1, 2016

Study Start

January 1, 2010

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

FR(1)