UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009195
Receipt number 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 12:39:42

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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 or person

Institute

Saitama Medical Center

Institute

Department

Personal name



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

Value
https://center6.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