Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder

Study acronym: AMAZE
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 2 years 4 months later Dec 31, 2026 → Apr 30, 2029
See other at-risk trials from University of Texas Southwestern Medical Center

Record History

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  1. Primary completion pushed from Dec 31, 2026 to Apr 30, 2029
    • Study completion pushed from Jun 30, 2027 to Oct 31, 2029
    • Eligibility criteria expanded, about 10 words
    • Study description expanded, about 4 words
  2. Site contact updatedv4
  3. Start date changed from estimate of Jul 1, 2024 to Jul 10, 2024v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 1, 2024 to Jul 1, 2024
    • Study sites: 0 to 1
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06398158
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: Alexion Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Neuromyelitis Optica
Related terms Neuromyelitis Optica
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov