Neuromyelitis Optica Spectrum Disorders Clinical Trial
Official title:
The French Cohort and Biobank of Devic's Neuromyelitis Optica and Related Neurological Disorders (NMOSD) (NOMADMUS)
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02836327 -
Multimodel Magnetic Resonance Imaging (MRI)of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders
|
N/A | |
| Recruiting |
NCT04146285 -
A Phase I Clinical Trial of BAT4406F Injection in Patients With Neuromyelitis Optica Spectrum Disorders
|
Phase 1 | |
| Not yet recruiting |
NCT06068829 -
Inebilizumab and Rituximab in Neuromyelitis Optica Spectrum Disorders
|
||
| Recruiting |
NCT05204459 -
MS-ResearchBiomarkerS
|
||
| Completed |
NCT03350633 -
Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders
|
Phase 2/Phase 3 | |
| Completed |
NCT04388072 -
An Diagnostic Cohort on AQP4-Immunoglobulin G Detection Kit
|
||
| Completed |
NCT05871658 -
Efficacy of Electroacupuncture in NMOSD Patients With Pain: Study Protocol
|
N/A | |
| Recruiting |
NCT02021825 -
Efficacy and Safety of Mitoxantrone in Patients With Refractory Neuromyelitis Optica and Spectrum Disorders
|
Phase 4 | |
| Recruiting |
NCT06249438 -
A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy
|
Phase 1 | |
| Not yet recruiting |
NCT06413654 -
A Phase II/III Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD)
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03330418 -
A Phase III Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Neuromyelitis Optica Spectrum Disorders
|
Phase 3 | |
| Enrolling by invitation |
NCT04101058 -
Treatment Response Among Chinese Neuromyelitis Optica Spectrum Disorders
|
||
| Enrolling by invitation |
NCT02809079 -
Mycophenolate Mofetil Treatment With Neuromyelitis Optica Spectrum Disorders in Chinese Patients
|
Phase 4 | |
| Recruiting |
NCT02889965 -
The French Multiple Sclerosis Registry
|
N/A | |
| Completed |
NCT04670770 -
An Open Label Study of the Effects of SHR1459 in NMOSDs Patients
|
Phase 2 | |
| Not yet recruiting |
NCT06212245 -
A Clinical Research Study of Inebilizumab in Neuromyelitis Optica Spectrum Disorders
|
Phase 4 | |
| Completed |
NCT03062579 -
A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSD
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05730699 -
Efficacy and Safety of Divozilimab in Patients With Neuromyelitis Optica Spectrum Disorders (AQUARELLE)
|
Phase 3 |