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NCT06398158 · ClinicalTrials.gov registry record
Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder
A clinical trial of Neuromyelitis Optica, sponsored by University of Texas Southwestern Medical Center.
- Recruiting
- Registry status
- 35
- Enrollment target
- 1
- Study location
NCT06398158: Recruiting study of Neuromyelitis Optica, sponsored by University of Texas Southwestern Medical Center.
NCT06398158 is a study of Neuromyelitis Optica that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 35 participants, below the 509-participant average among 7 other Neuromyelitis Optica trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06398158, a study of Neuromyelitis Optica, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.
- RECRUITING
- Registry status
- 35 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Compare the number of participants with adjudicated clinical relapses both pre- and post-ravulizumab treatment
Conditions Studied
Interventions
- DRUG Ravulizumab
Study Locations (1)
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2024-07-10 |
| Est. Completion | 2027-06-30 |
What NCT06398158 shows while recruiting
NCT06398158 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 509-participant average among 7 other Neuromyelitis Optica trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Neuromyelitis Optica appearing as the primary indexed condition, and to 1 intervention - of which Ravulizumab is the first listed.
NCT06398158 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06398158 about?
NCT06398158 is a clinical study titled "Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder". 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 ...
What is the current status of trial NCT06398158?
This trial is currently recruiting. The enrollment target is 35 participants. The study started on 2024-07-10. Estimated completion is 2027-06-30.
What conditions does trial NCT06398158 study?
This clinical trial studies the following conditions: Neuromyelitis Optica.
What interventions are being tested in trial NCT06398158?
The interventions under investigation include: Ravulizumab (DRUG).
Who is sponsoring clinical trial NCT06398158?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06398158 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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