Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies

StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Enrollment increased: 122 → 200 participants
    • Start date: Feb 1, 2024 to Aug 30, 2023
    • Eligibility criteria expanded, about 5 words
  2. Primary and study completion moved earlier from Mar 1, 2030 to Sep 27, 2029v6
  3. Re-verified, no change to tracked fieldsv5
  4. Primary and study completion dates: Mar 4, 2030 to Mar 1, 2030v4
  5. Primary and study completion dates: Sep 30, 2026 to Mar 4, 2030
    • Start date: Aug 30, 2023 to Feb 1, 2024
    • Study sites: 1 to 33
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jul 31, 2029 to Sep 30, 2026
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 30, 2023 to Aug 30, 2023
    v2
  7. 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.
AstraZeneca
734 trials monitored
See 61 trials at risk
Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD.
Trial Details
NCT Number NCT05966467
Lead Sponsor Alexion Pharmaceuticals, Inc.
Conditions
(from sponsor)		 Neuromyelitis Optica Spectrum Disorder, NMOSD, AQP4+ NMOSD
Related terms Neuromyelitis Optica
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov