The French Cohort and Biobank of Devic's Neuromyelitis Optica and Related Neurological Disorders (NMOSD) (NOMADMUS)

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT02850705

Collaborator

(none)

1,787

Enrollment

Location

142

Actual Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuromyelitis Optica Spectrum Disorders Neuromyelitis Optica Spectrum Related Disorders

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

1787 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

The French Cohort and Biobank of Devic's Neuromyelitis Optica and Related Neurological Disorders (NMOSD) (NOMADMUS)

Actual Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Nov 1, 2021

Actual Study Completion Date :

Nov 1, 2021

Outcome Measures

Primary Outcome Measures

number of cases of NMO or NMOSD included in the cohort [At 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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