NCT06398158 Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder
| NCT ID | NCT06398158 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Neuromyelitis Optica |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35 participants in total. It began in 2024-07-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 \<7.0 Exclusion Criteria: 1. Individuals who are intolerant to MRI 2. Individuals previously exposed to eculizumab with treatment discontinuation due to lack of effective disease control (i.e., clinical relapse or demonstration of MRI advancement after 12 weeks of sustained treatment exposure) 3. Unresolved meningococcal disease 4. History of an active infection 5. Existing participation in neuromyelitis optical spectrum disorder interventional clinical studies 6. Pregnant or lactating women
Contact & Investigator
Darin T. Okuda, MD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT06398158 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuromyelitis Optica. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06398158 currently recruiting?
Yes, NCT06398158 is actively recruiting participants. Contact the research team at diemh.tran@utsouthwestern.edu for enrollment information.
Where is the NCT06398158 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06398158 clinical trial?
NCT06398158 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Darin T. Okuda, MD at University of Texas Southwestern Medical Center. The trial plans to enroll 35 participants.