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NCT07526298

Anticipating Irreversible Disability in Neuromyelitis Optica Spectrum Disorder: a Study to Assess Disease Activity in Apparently Stable Patients

Not yet recruiting Last updated 13 April 2026
What this trial tests

trial testing MRI in Neuromyelitis Optica Spectrum Disorders in 50 participants. Not yet recruiting.

Timeline
1 April 2026
Primary endpoint
1 April 2027
1 April 2027

Quick facts

Lead sponsorIRCCS San Raffaele
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment50
Start date1 April 2026
Primary completion1 April 2027
Estimated completion1 April 2027
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

IRCCS San Raffaele — full company profile →

Who can join

18 and older, any sex, with Neuromyelitis Optica Spectrum Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The present research is an observational clinical study. The project aims to investigate astrocytic damage, assessed through biological findings such as an increase in GFAP level and/or MRI water index, in patients with NMOSD and its potential role in predicting demyelinating relapses or affecting disability outcomes. It will also explore predictors of astrocytic relapses, focusing on demographic, clinical, and immunological biomarkers like T cell responses, B cell repopulation, and cytokine levels. The goal is to identify unrecognized disease activity, providing insights for future research and clinical trials. The study will involve 8 sites in Italy: 6 NMOSD clinical centers for patient enrolment and 2 centers for bioengineering and biological analysis. Centralized analysis of the MRI images of all patients enrolled in the clinical centers will be performed by the Neuroimaging Research Unit Fase 1 of San Raffaele Hospital. A total of 50 patients will be included and they will be followed for 12 months. Comprehensive evaluation of patients, including clinical assessment, bioengineering evaluation, MRI, and blood samples, will be conducted at baseline, month 6, and month 12. To assess silent astrocytic relapses, a specialized evaluation will take place at months 3 and 9, including clinical analysis, blood samples to assess biomarkers like GFAP, a reduced MRI protocol to assess MRI water index, and bioengineering evaluation. In the case of a classical relapse, a dedicated visit will occur within 5 days of symptom onset, using the same evaluation protocol as at months 3 and 9 (MRI and biomarkers will be evaluated if not done in the month before).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of MRI

Trials testing the same drug.

Other recruiting trials for Neuromyelitis Optica Spectrum Disorders

Currently open trials in the same condition.

Other IRCCS San Raffaele trials

Trials by the same sponsor.

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Data sources for this page

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