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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02003144




Registration number
NCT02003144
Ethics application status
Date submitted
18/11/2013
Date registered
6/12/2013
Date last updated
18/12/2019

Titles & IDs
Public title
An Open Label Extension Trial of Eculizumab in Relapsing NMO Patients
Scientific 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)
Secondary ID [1] 0 0
2013-001151-12
Secondary ID [2] 0 0
ECU-NMO-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neuromyelitis Optica 0 0
Neuromyelitis Optica Spectrum Disorder 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Neurological 0 0 0 0
Other neurological disorders
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - eculizumab

Experimental: Eculizumab - Eculizumab intravenous infusion every two weeks.


Other interventions: eculizumab


Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluate the long-term safety of eculizumab in patients with relapsing NMO. - 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)
Timepoint [1] 0 0
From first dose to study completion (maximum of 4 years).
Secondary outcome [1] 0 0
Evaluate the long-term efficacy of eculizumab in patients with relapsing NMO - Change from baseline in Annualized Relapsing Rate, disability, quality of life and neurologic function.
Timepoint [1] 0 0
From first dose to study completion (maximum of 4 years).

Eligibility
Key inclusion criteria
Key

1. Patient completed the ECU-NMO-301 trial

2. Patient has given written informed consent

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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 Patients who have withdrawn from the ECU-NMO-301 trial as a result of an AE related to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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Brain and Mind Research Institute - Camperdown
Recruitment hospital [2] 0 0
St. Vincent's Hospital - Fitzroy
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Minnesota
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United States of America
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Missouri
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New York
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Ohio
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Pennsylvania
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United States of America
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Texas
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United States of America
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Utah
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Ciudad Autonoma, Buenos Aires,
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Argentina
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Ciudad Autonoma, Buenos Aires
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Canada
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Ontario
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Colombia
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Santander
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Croatia
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Zagreb
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Czechia
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Praha
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Czechia
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Teplice
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Denmark
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Arhus
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Germany
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Baden Wuerttemberg
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Germany
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Bayern
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Germany
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Nordrhein Westfalen
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Germany
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Rostock
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Hong Kong
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Shatin
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Italy
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Catania
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Italy
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Napoli
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Italy
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Padova
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Italy
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Rome
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Japan
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Chiba-Ken
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Japan
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HyogoKen
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Japan
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Kyoto-Fu
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Japan
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Miyagi-Ken
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Japan
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Yamaguchi-Ken
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Japan
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Fukuoka
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Japan
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Tokio
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seoul
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Malaysia
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Sarawak
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Malaysia
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Kuala Lumpur
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Russian Federation
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Kazan
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Novosibirsk
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Russian Federation
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Rostov-on Don
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Spain
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Bizkaia
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Spain
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Cordoba
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Spain
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Madrid
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Taiwan
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Taipei
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Thailand
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Pathum Thani
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Turkey
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Ankara
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Turkey
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Edirne
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Samsun
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alexion Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether eculizumab long-term use is safe and
effective in patients with relapsing NMO.
Trial website
https://clinicaltrials.gov/show/NCT02003144
Trial related presentations / publications
Pittock SJ, Lennon VA, McKeon A, Mandrekar J, Weinshenker BG, Lucchinetti CF, O'Toole O, Wingerchuk DM. Eculizumab in AQP4-IgG-positive relapsing neuromyelitis optica spectrum disorders: an open-label pilot study. Lancet Neurol. 2013 Jun;12(6):554-62. doi: 10.1016/S1474-4422(13)70076-0. Epub 2013 Apr 26.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications