UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004597 |
|---|---|
| Receipt number | R000005484 |
| Scientific Title | Safety and efficacy of Edaravone[Nichiiko] in patients with acute noncardiogenic brain embolism |
| Date of disclosure of the study information | 2010/12/03 |
| Last modified on | 2012/06/15 12:38:21 |
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Basic information
Public title
Safety and efficacy of Edaravone[Nichiiko] in patients with acute noncardiogenic brain embolism
Acronym
Safety and efficacy of Edaravone[Nichiiko] in patients with acute noncardiogenic brain embolism
Scientific Title
Safety and efficacy of Edaravone[Nichiiko] in patients with acute noncardiogenic brain embolism
Scientific Title:Acronym
Safety and efficacy of Edaravone[Nichiiko] in patients with acute noncardiogenic brain embolism
Region
| Japan |
Condition
Condition
acute noncardiogenic brain embolism
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to examine safety and efficacy of Edaravone [Nichiiko] in patients with acute noncardiogenic brain embolism
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety
The investigators examined adverse event, unusual change in laboratory values and vital sign
Key secondary outcomes
Efficacy
1)mRS:at 4 weeks, 3 months after administration
2)NIHSS:at the end of administration, and at 4 weeks, 3 months after administration
3)JCS:at the end of administration
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
administration of Edaravone 30mg IV drip BID for 7-14 days
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the investigators must ensure that all subjects being considered to meet the following inclusion criteria:
1)Atherothrombotic cerebral infarction or lacunar infarction
2)Over 20 years of age on the day of signing informed consent
3)Patients or legal representatives whose agreement is obtained by the document
4)Patients who develop the symptoms within 24 hours before starting the administration of the investigational drug
5)JCS <= 30
6)Patients have motor dysfunction of upper and/or inferior limb
Key exclusion criteria
the investigators must ensure that all subjects being considered to meet the following exclusion criteria or conditions:
1)difficult lifesaving in a coma
2)serum creatinine >= 1.5 mg/dL
3)history of allergy to Edaravone
4)cardiogenic brain embolism
5)hemorrhagic infarction, epidural hemorrhage, intracerebral hemorrhage, intraventricular hemorrhage
6)transient ischemic attack
7)patients are less than 3 months from the last onset in case of reappearance
8)mRS before the onset >= grade 2
9)patients who are administrated the excluded drugs between onset and investigational drug administration
10)patients who are recieved the excluded therapies between onset and investigational drug administration
11)A serious heart disease(e.g heart failure) or hepatic disease(e.g cirrhosis hepatis) to need hospitalization treatment
12)Patients have cancer
13)Patients who are or may be pregnant, who are lactating
14)recent (past 3 months) participation in other clinical trial for investigational agent,the investigator determines this trial participation inadequate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Yamada |
Organization
Saiseikai Fukuoka General Hospital
Division name
Depertment of Neurology
Zip code
Address
1-3-46,Tenjin Chuo-ku,Fukuoka-City,Japan
TEL
092-771-8151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fuminori Higashihara |
Organization
Neues Corporation
Division name
Clinical Research Support
Zip code
Address
6-18,Tenya machi Hakata-ku,Fukuoka-City,Japan
TEL
092-283-7100
Homepage URL
higashihara.fuminori@neues.co.jp
Sponsor or person
Institute
Takeshi Yamada
Institute
Department
Personal name
Funding Source
Organization
NPO HEART
Organization
Division
Category of Funding Organization
Non profit foundation
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
済生会福岡総合病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 03 | 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
| 2010 | Year | 10 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 22 | Day |
Last modified on
| 2012 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005484
