An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
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|ClinicalTrials.gov Identifier: NCT02003144|
Recruitment Status : Active, not recruiting
First Posted : December 6, 2013
Last Update Posted : December 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder||Biological: eculizumab||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||119 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Eculizumab intravenous infusion every two weeks.
Other Name: Soliris
- Evaluate the long-term safety of eculizumab in patients with relapsing NMO. [ Time Frame: From first dose to study completion (maximum of 4 years). ]Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs), change from baseline in vital signs, clinical laboratory tests, and suicide risk as assessed with Columbia-Suicide Rating Scale (C-SSRS)
- Evaluate the long-term efficacy of eculizumab in patients with relapsing NMO [ Time Frame: From first dose to study completion (maximum of 4 years). ]Change from baseline in Annualized Relapsing Rate, disability, quality of life and neurologic function.
- Describe the pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab in patients with relapsing NMO [ Time Frame: From first dose to study completion (maximum of 4 years). ]Change in plasma PK of eculizumab and in free C5 activity (PD marker) before and after treatment with the study drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003144