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Recruiting
NCT06398158
Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder
Conditions: Neuromyelitis Optica
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 35
Sponsor: University of Texas Southwestern Medical Center
Location: UT Southwestern Medical Center Dallas Texas
Summary
This is an observational study to:
* evaluate the on-treatment clinical performance of ravulizumab in relation to the pre-treatment time period (time period prior to exposure),
* enhance knowledge regarding conventional MRI outcomes in people with NMOSD treated with ravulizumab,
* identify factors suggestive of subclinical disease progression through conventional MRI sequences,
* determine if treatment with ravulizumab, impacts longitudinal 3D conformational MRI measures at the dorsal medulla and other regions of the CNS, and
* identify biomarkers (e.g., serum neurofilament light chain (sNfL), conventional and novel MRI markers, etc.) related to disease activity.
Eligibility Criteria
Inclusion Criteria:
1. Signed informed consent available prior to conduct of any study associated activities
2. Men and women \> 18 years of age
3. Aquaporin-4 IgG positive people with neuromyelitis optica spectrum disorder treated with commercially available ravulizumab in a manner consistent with the approved indication
4. Expanded Disability Status Scale score of \
Source: ClinicalTrials.gov (NCT06398158). StuddyBuddy aggregates publicly available trial information.