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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
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this study is to determine whether eculizumab long-term use is safe and effective in patients with relapsing NMO.

Condition or disease Intervention/treatment Phase
Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder Biological: eculizumab Phase 3

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.

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Eculizumab
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Eculizumab
Eculizumab intravenous infusion every two weeks.
 Biological: eculizumab
Other Name: Soliris


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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:
  1. 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.


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

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
Contacts and Locations
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Information from the National Library of Medicine

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


  Show 88 Study Locations
Sponsors and Collaborators
Alexion Pharmaceuticals
More Information
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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