An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by Alexion Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02003144
First received: November 18, 2013
Last updated: December 2, 2013
Last verified: December 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:


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). ] [ Designated as safety issue: Yes ]
    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). ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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: March 2014
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
Genders Eligible for Study:   Both
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
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

Contacts
Contact: Alexion Pharmaceuticals (Sponsor) clinicaltrials@alxn.com

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
Study First Received: November 18, 2013
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alexion Pharmaceuticals:
Neuromyelitis Optica Spectrum Disorder
Devic's disease
Long-term safety study
Extension trial
Eculizumab
Transverse Myelitis
Optic Neuritis
Relapse
NMO-IgG
CNS Autoimmune Disorders
Demyelinating Disorders

Additional relevant MeSH terms:
Neuromyelitis Optica
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Myelitis, Transverse
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Demyelinating Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014