NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JMACCT ID: JMA-IIA00023

Registered date:19/11/2008

Investigator mediated Phase III open labeled L-arginine clinical trial on the acute phase of stroke-like episodes in MELAS

Basic Information

Recruitment status Completed
Health condition(s) or Problem(s) studiedmitochondrial myopathy (MELAS with an A3243G mutation)
Date of first enrollment20/11/2008
Target sample size18
Countries of recruitmentJapan
Study typeINTERVENTIONAL
Intervention(s)Intervention type:DRUG. Intervention1:L-arginine, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:intravenous infusion of 5ml/kg/dose of 10% L-arginine-HCl solution for one hour to MELAS who come to the hospital within 6 hours from the onset of stroke-like episodes. Control intervention1:none.

Outcome(s)

Primary Outcomeheadache, vomit. Timepoint:2 hours after L-arginine infusion.
Secondary Outcomeconvulsion, unconsciousness, blindness. Timepoint: 2 hours after L-arginine infusion.

Key inclusion & exclusion criteria

Age minimumNo Limit
Age maximumNo Limit
GenderBOTH
Include criteriaMELAS who fulfilled the Japanese diagnostic criteria of MELAS and has an A3243G mutation, and who come to the hospital within 6 hours after the onset of stroke-like episodes
Exclude criteria1) patient who has status epileptics or having unconsiousness 2) patient who has dementia or bed ridden status 3) patient who has more than 7% of HbA1c or receiving insulin therapy 4) patient who has septic state 5) patient who has arginase deficiency 6) patient who has hepatic or renal failure 7) patient who has cardiac infarction or has the history of cardiac infarction 8) patient who received the nitric-oxide related drug 1 week before their enrolment 9) patient who receive the edaravon 12 hours before enrolment 10) patient who is pregnant or possible to be pregnant 11) patient who has been enrolled to other clinical trial within 6 months. 12) patient whose enrolment is thought to be not adequate by responsible doctor

Related Information

Contact

public contact
Name Yasutoshi Koga
Address Department of Pediatrics and Child Health, School of Medicine,67 Asahi-machi, Kurume, Fukuoka, Japan 830-0011
Telephone +81-942-31-7565
E-mail yasukoga@med.kurume-u.ac.jp
Affiliation Kurume University
scientific contact
Name Yasutoshi Koga
Address Department of Pediatrics and Child Health, School of Medicine,67 Asahi-machi, Kurume, Fukuoka, Japan 830-0011
Telephone +81-942-31-7565
E-mail
Affiliation Kurume University