An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
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ClinicalTrials.gov Identifier: NCT02003144 |
Recruitment Status
:
Enrolling by invitation
First Posted
: December 6, 2013
Last Update Posted
: March 8, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder | Biological: eculizumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 132 participants |
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) |
Study Start Date : | January 2015 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | December 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Eculizumab
Eculizumab intravenous infusion every two weeks.
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Biological: eculizumab
Other Name: Soliris
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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). ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

Publications:
Responsible Party: | Alexion Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02003144 History of Changes |
Other Study ID Numbers: |
ECU-NMO-302 2013-001151-12 ( EudraCT Number ) |
First Posted: | December 6, 2013 Key Record Dates |
Last Update Posted: | March 8, 2018 |
Last Verified: | March 2018 |
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 |