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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009195
Receipt No. R000010795
Scientific Title Efficacy and safety of plasma exchange and immunoadsorption plasmapheresis for neuromyelitis optica: Multicenter double-blind controlled study using dynamic allocation
Date of disclosure of the study information 2012/12/01
Last modified on 2016/11/22

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Basic information
Public title Efficacy and safety of plasma exchange and immunoadsorption plasmapheresis for neuromyelitis optica: Multicenter double-blind controlled study using dynamic allocation
Acronym Controlled study of plasma exchange and immunoadsorption plasmapheresis for neuromyelitis optica
Scientific Title Efficacy and safety of plasma exchange and immunoadsorption plasmapheresis for neuromyelitis optica: Multicenter double-blind controlled study using dynamic allocation
Scientific Title:Acronym Controlled study of plasma exchange and immunoadsorption plasmapheresis for neuromyelitis optica
Region
Japan

Condition
Condition Neuromyelitis optica
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this controlled study is to compare the efficacy and safety of plasma exchange (PE) and immunoadsorption plasma-pheresis (IAPP) for steroid-resistant neuromyelitis optica (NMO).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in QOSI score on day 7 after the first course of blood purification therapy
Key secondary outcomes Anti-AQP4 antibody titer during evaluation period
Initial effect
Steroid pulse therapy efficacy rate
Crossover study implementation rate
Crossover study efficacy
Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Plasma exchange (PE group): Will be performed 4 times within 14 days after the efficacy of the steroid pulse therapy has been evaluated, for each session, the final volume of treated plasma is 30mL/kg.
Interventions/Control_2 Immunoadsorption plasmapheresis (IAPP group): Will be performed 4 times within 14 days after the efficacy of the steroid pulse therapy has been evaluated, for each session, the final volume of treated plasma is 30mL/kg.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with optic neuritis or myelitis who either initially presented with NMO or NMO spectrum disorders
suspected to be positive for the anti-AQP4 antibody titer or tested positive for the anti-AQP4 antibody titer, and who have been diagnosed with relapsing NMO or NMO spectrum disorders in a period of acute exacerbation
Key exclusion criteria Patients considered to be due to brain lesions, the only local symptoms and disturbance of consciousness.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoichi Nomura
Organization Saitama Medical Center
Division name Department of Neurology
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL 049-228-3603
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kyoichi Nomura
Organization Saitama Medical Center
Division name Department of Neurology
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL 049-228-3603
Homepage URL
Email

Sponsor
Institute Saitama Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 埼玉医科大学総合医療センター(埼玉県)

Other administrative information
Date of disclosure of the study information
2012 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 26 Day
Last modified on
2016 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010795

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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