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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
NCT02003144 |
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Date of registration:
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18/11/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
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Scientific title:
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A Phase III, Open-label, Extension Trial of ECU-NMO-301 to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO) |
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Date of first enrolment:
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January 31, 2015 |
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Target sample size:
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119 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02003144 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Australia
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Austria
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Canada
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Colombia
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Croatia
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Czech Republic
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Czechia
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Denmark
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France
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Germany
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Hong Kong
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Italy
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Japan
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Korea, Republic of
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Malaysia
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Russian Federation
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Singapore
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Spain
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Taiwan
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Thailand
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Turkey
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
1. Patient completed the ECU-NMO-301 trial
2. Patient has given written informed consent
Key Exclusion Criteria:
1. Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to
trial drug
2. Female patients who are pregnant, breastfeeding, or intend to conceive during the
course of the trial
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neuromyelitis Optica
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Neuromyelitis Optica Spectrum Disorder
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Intervention(s)
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Biological: eculizumab
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Primary Outcome(s)
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Evaluate the long-term safety of eculizumab in patients with relapsing NMO.
[Time Frame: From first dose to study completion (maximum of 4 years).]
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Secondary Outcome(s)
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Evaluate the long-term efficacy of eculizumab in patients with relapsing NMO
[Time Frame: From first dose to study completion (maximum of 4 years).]
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Secondary ID(s)
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2013-001151-12
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ECU-NMO-302
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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