UMIN-CTR Clinical Trial

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

acute noncardiogenic brain embolism

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

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

Email

higashihara.fuminori@neues.co.jp

Institute

Takeshi Yamada

Institute

Department

Personal name

Organization

NPO HEART

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

済生会福岡総合病院（福岡県）

Date of disclosure of the study information

2010

Year

12

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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