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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000010052
Receipt No. R000011769
Scientific Title Effect of edaravone against consciousness impairment after encephalitis
Date of disclosure of the study information 2013/02/15
Last modified on 2016/08/19

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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
Middle name
Last name Akiko Ishii
Organization University of Tsukuba
Division name Neurology
Zip code
Address 1-1-1 Tennoudai Tuskuba
TEL 029-853-3224
Email a_ishii@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Ishii
Organization University of Tsukuba
Division name Neurology
Zip code
Address 1-1-1 Tennoudai Tuskuba
TEL 029-853-3224
Homepage URL
Email neurol@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba
Organization
Division
Category of Funding Organization Other
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 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 Suspended
Date of protocol fixation
2013 Year 02 Month 18 Day
Date of IRB
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
2016 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011769

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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