STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTS

Phase 1

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

• Registration Number: EUCTR2013-001150-10-AT
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-17
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

- Male or female patient = 18 years old
- Diagnosis of NMO or NMO spectrum disorder
- NMO-IgG seropositive
- Historical Relapse of at least 2 relapses in the last 12 months or 3 relapses in the last 24 months, with at least 1 relapse in the 12 months prior to the Screening
- EDSS score =7
- Immunosuppressive therapy is allowed provided patients have been on
a stable maintenance dose prior to the Screening and remain on a stable dose for the duration of the study
- Patients must be willing and able to give 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 119
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion Criteria

- Use of rituximab or mitoxantrone within 3 months prior to screening
- Use of IVIg within 3 weeks prior to screening

Study & Design

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