acute noncardiogenic brain embolism
Conditions
Interventions
administration of Edaravone 30mg IV drip BID for 7-14 days
Sponsors
Takeshi Yamada
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety The investigators examined adverse event, unusual change in laboratory values and vital sign | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactFuminori Higashihara
Neues Corporation Clinical Research Support
Outcome results
None listed