UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010094 |
|---|---|
| Receipt number | 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 20:08:58 |
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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
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
nakashima@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011205
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