EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

Phase 1

• Conditions: Relapsing Neuromyelitis Optica; MedDRA version: 18.0 Level: PT Classification code 10029322 Term: Neuromyelitis optica System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-001151-12-FR
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-25
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 93

Inclusion Criteria

- Male or female patient = 18 years old
- Patient who completed the ECU-NMO-301 trial
- Patients who completed written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

- Patient withdrew 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
- Any medical condition or circumstances that, in the opinion of the Investigator, might interfere with the patient’s participation in the trial, pose any added risk for the patient, or confound the assessment of the patients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Long-term safety of eculizumab in patients with relapsing NMO. ;<br> Secondary Objective: Long-term efficacy of eculizumab in patients with relapsing NMO Describe the pharmacokinetics (PK) and pharmacodynamics (PD) of eculizumab in relapsing NMO patients.<br> <br> ;Primary end point(s): - Safety: Trial emergent adverse effects;Timepoint(s) of evaluation of this end point: Trial period

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - On-Trial relapse<br> - EDSS and mRS score change from baseline<br> - FSS score<br> - Quality of life<br> ;<br> Timepoint(s) of evaluation of this end point: Evaluation at:<br> - Blind induction phase (day 1, week 4)<br> - Open label phase (week 8, 12, 26, 40, 52, 66, 78, 92, 116, 130, 144, 170, 182, 196)<br> - Relapse Evaluation Visits (within 48 hours, and at week +1, 4 weeks, 6 weeks after relapse)<br> - End of trial visit (week 104 or 156 or 208)<br>