UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010052 |
|---|---|
| Receipt number | R000011769 |
| Scientific Title | Effect of edaravone against consciousness impairment after encephalitis |
| Date of disclosure of the study information | 2013/02/15 |
| Last modified on | 2023/08/24 20:31:02 |
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Basic information
Public title
Effect of edaravone against consciousness impairment after encephalitis
Acronym
Effect of edaravone against consciousness impairment after encephalitis
Scientific Title
Effect of edaravone against consciousness impairment after encephalitis
Scientific Title:Acronym
Effect of edaravone against consciousness impairment after encephalitis
Region
| Japan |
Condition
Condition
Limbic encephalitis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate efficiency of edaravone against consciousness impairment after encephalitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
improvement of Glasgow coma scale
Key secondary outcomes
Japan coma scale, HDSR,MMSE,Barthel index
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
injection of edaravone
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed with limbic encephalitis patients who had obtained consent from the person or family.
Key exclusion criteria
1.male:Cre<1.3 mg/dl Female:Cre<1.0 mg/dl
male & femaile:AST/ALT<more than three times the reference value
2.sepsis
3.epilepticus and severe coma
4.bacterial meningitis and encephalitis
5.DIC
6.allergy for edaravone
7. edaravone is used within two weeks prior to registration
8.acute cereberal infarction
9.Patients within 6 months after the end of the other trial
10.investigator has determined the patient disqualified as a target
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Ishii |
Organization
University of Tsukuba
Division name
Neurology
Zip code
3058575
Address
1-1-1 Tennoudai Tuskuba
TEL
029-853-3224
a_ishii@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Ishii |
Organization
University of Tsukuba
Division name
Neurology
Zip code
3058575
Address
1-1-1 Tennoudai Tuskuba
TEL
029-853-3224
Homepage URL
neurol@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1Tennoudai Tsukuba
Tel
0298533224
neurol@md.tsukuba.ac.jp
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
筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 15 | 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
Completed
Date of protocol fixation
| 2013 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 15 | Day |
Last modified on
| 2023 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011769
