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An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients

Alexion Pharmaceuticals logo

Alexion Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Neuromyelitis Optica
Neuromyelitis Optica Spectrum Disorder

Treatments

Biological: eculizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT02003144
2013-001151-12 (EudraCT Number)
ECU-NMO-302

Details and patient eligibility

About

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

Full 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.

Enrollment

119 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to trial drug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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

119 participants in 1 patient group

Eculizumab
Experimental group
Description:
Eculizumab intravenous infusion every two weeks.
Treatment:
Biological: eculizumab

Trial documents
2

Trial contacts and locations

69

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Data sourced from clinicaltrials.gov

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