UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of plasma exchange and immunoadsorption plasmapheresis for neuromyelitis optica: Multicenter double-blind controlled study using dynamic allocation
Title of the study (Brief title)	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	Kyoichi Nomura
Organization	Saitama Medical Center
Division name	Department of Neurology
Address	1981 Kamoda, Kawagoe-shi, SAITAMA 350-8550, JAPAN
TEL	049-228-3603
Email

Public contact
Name of contact person	Kyoichi Nomura
Organization	Saitama Medical Center
Division name	Department of Neurology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 07 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000010795