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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010094
Receipt No. R000011205
Scientific Title A pilot study of Elaspol (Sivelestat Sodium) for neuromyelitis optica
Date of disclosure of the study information 2013/04/01
Last modified on 2015/08/22

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Basic information
Public title A pilot study of Elaspol (Sivelestat Sodium) for neuromyelitis optica
Acronym A pilot study of Elaspol (Sivelestat Sodium) for neuromyelitis optica
Scientific Title A pilot study of Elaspol (Sivelestat Sodium) for neuromyelitis optica
Scientific Title:Acronym A pilot study of Elaspol (Sivelestat Sodium) for neuromyelitis optica
Region
Japan

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

Objectives
Narrative objectives1 Safety and efficacy of 5 days injection of Elaspol will be assessed in combination with a standard treatment, intravenous methyl-prednisolone pulse therapy, for an acute phase of neuromyelitis optica.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety and Expanded Disability Status Scale (EDSS) change after 5 days treatment and one month after the treatment
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 4.8mg/kg Sivelestat Sodium will administered constantly for 5 days in combination with 3 days intravenous methyl-prednisolone administration to sero-positive neuromyelitis optica patients who relapsed within 72 hours before starting treatment.
Interventions/Control_2
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
55 years-old >=
Gender Male and Female
Key inclusion criteria 1) Neuromyelitis optica or Neuromyelitis optica spectrum disorder who are positive for serum anti-aquaporin-4 antibody.
2) Patients who relapsed by one of the symptoms listed below.
a. unilateral of bilateral optic neuritis.
b. myelitis.
3) Patients whose site of lesion was detected by MRI.
4) Patients who can sign on a printed form of informed consent by themselves.
Key exclusion criteria 1) Patients with multiple sclerosis.
2) Patients with severe cardiac disease, severe liver disease, severe lung disease, severe gastrointestinal disease, severe kidney disease, immunodeficiency disease, or other diseases which organizer consider to be inappropriate.
3) Patients who have more than four organs dysfunction.
4) Patients who have or had asthma which requires continuous treatment.
5) Patients who have or had malignant diseases.
6) Patients who have severe autoimmune inflammatory diseases.
7) Patients with systemic infection including bacterial, viral, fungal, HBV, HCV, and HIV.
8) Patients who can not assess by MRI with gadolinium enhancement.
9) Patients who have received treatments listed below after the relapse.
a. steroid pulse therapy
b. plasmapheresis
10) Patients with increased serum transaminase levels.
AST: higher than 5 times reference range
ALT: higher than 5 times reference range
11) Patients with alcoholism.
12) Patients who had entered other clinical trials within 3 months.
13) Patients with pregnancy.
14) Patients with breastfeeding.
15) Patients who have severe allergic reactions.
16) Patients who can't cooperate with medical stuff.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Fujihara
Organization Tohoku University Graduate School of Medicine
Division name Department of Multiple Sclerosis Therapeutics
Zip code
Address 1-1 Seiryo-machi, Aoba-ku
TEL 022-717-7189
Email nakashima@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ichiro Naksahima
Organization Tohoku University Hospital
Division name Department of Neurology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku
TEL 022-717-7189
Homepage URL
Email nakashima@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Hospital
Institute
Department

Funding Source
Organization Department of Multiple Sclerosis Therapeutics, Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2013 Year 04 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
2013 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 02 Month 22 Day
Last modified on
2015 Year 08 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011205

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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