NCT05966467 Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
| NCT ID | NCT05966467 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alexion Pharmaceuticals, Inc. |
| Condition | Neuromyelitis Optica Spectrum Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 122 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2029-09-27 |
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 122 participants in total. It began in 2024-02-01 with a primary completion date of 2029-09-27.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: * Participant is ≥ 18 years of age at the time of enrollment in the Registry. * Participant must have a confirmed diagnosis of AQP4+ NMOSD. * At the time of enrollment in the Registry, participants must be receiving treatment with ALXN-C5IT for the purpose of chronic relapse prevention in a manner consistent with the local label. Specifically, they should have received at least 1 dose of eculizumab within 4 weeks prior to enrollment or at least 1 dose of ravulizumab within 12 weeks prior to enrollment. * Participants must have both the following historical data available to be enrolled in the Registry: ALXN-C5IT dosing information since initiation and number and types of relapses from 1 year prior to ALXN-C5IT initiation through Registry enrollment. Exclusion Criteria: * Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.
Contact & Investigator
Pablo Lopez
PRINCIPAL INVESTIGATOR
Hospital Aleman
Frequently Asked Questions
Who can join the NCT05966467 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuromyelitis Optica Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05966467 currently recruiting?
Yes, NCT05966467 is actively recruiting participants. Contact the research team at clinicaltrials@alexion.com for enrollment information.
Where is the NCT05966467 trial being conducted?
This trial is being conducted at Washington D.C., United States, Boston, United States, Chapel Hill, United States, Columbus, United States and 11 additional locations.
Who is sponsoring the NCT05966467 clinical trial?
NCT05966467 is sponsored by Alexion Pharmaceuticals, Inc.. The principal investigator is Pablo Lopez at Hospital Aleman. The trial plans to enroll 122 participants.