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An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
This study is enrolling participants by invitation only.
Sponsor:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02003144
First received: November 18, 2013
Last updated: February 1, 2017
Last verified: February 2017
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Purpose
The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.
| Condition | Intervention | Phase |
|---|---|---|
| Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder | Biological: eculizumab | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
neuromyelitis optica
Drug Information available for:
Eculizumab
Genetic and Rare Diseases Information Center resources:
Myelitis
Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder
Transverse Myelitis
Optic Neuritis
U.S. FDA Resources
Further study details as provided by Alexion Pharmaceuticals:
Primary Outcome Measures:
- 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)
Secondary Outcome Measures:
- 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.
Other Outcome Measures:
- 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.
| Estimated Enrollment: | 132 |
| Study Start Date: | January 2015 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Eculizumab
Eculizumab intravenous infusion every two weeks.
|
Biological: eculizumab
Other Name: Soliris
|
Detailed Description:
This study is an open label extension study to confirm the long term safety and efficacy of eculizumab in subjects with relapsing NMO who have completed the initial double-blind, randomized, placebo-controlled trial ECU-NMO-301.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Patient completed the ECU-NMO-301 trial
- Patient has given written informed consent
Key Exclusion Criteria:
- Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug
- Female patients who are pregnant, breastfeeding, or intend to conceive during the course of the trial
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02003144
Show 113 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02003144
Show 113 Study Locations
Sponsors and Collaborators
Alexion Pharmaceuticals
More Information
Publications:
| Responsible Party: | Alexion Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02003144 History of Changes |
| Other Study ID Numbers: |
ECU-NMO-302 2013-001151-12 ( EudraCT Number ) |
| Study First Received: | November 18, 2013 |
| Last Updated: | February 1, 2017 |
Keywords provided by Alexion Pharmaceuticals:
|
Transverse Myelitis Long-term safety study Extension trial Eculizumab Neuromyelitis Optica Spectrum Disorder Devic's disease |
Optic Neuritis Relapse NMO-IgG CNS Autoimmune Disorders Demyelinating Disorders |
Additional relevant MeSH terms:
|
Neuromyelitis Optica Myelitis, Transverse Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Optic Neuritis |
Optic Nerve Diseases Cranial Nerve Diseases Demyelinating Diseases Eye Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on August 17, 2017