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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
