mitochondrial myopathy (MELAS with an A3243G mutation)
Conditions
Interventions
Intervention type:DRUG
Name of intervention:IIS-MELAS002
Dose form / Japanese Medical Device Nomenclature:GRANULES
Route of administration / Site of application:ORAL
Dose per administration:0.1
0.3g/k
Sponsors
Yasutoshi Koga, Department of Pediatrics and Child Health, Kurume University School
of Medicine
Center of Clinical Trial, Japan Medical Association
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: MELAS who fulfilled the Japanese diagnostic criteria of MELAS and has 1) stroke-like episodes within 2 years, 2) an A3243G mutation, 3) has no history of L-arginine supplementation therapy, and 4) recognize the symptoms relating the MELAS stroke scale.
Exclusion criteria
Exclusion criteria: 1) patient who has dementia or bed ridden status 2) patient who has more than 7% of HbA1c or receiving insulin therapy 3) patient who has septic state 4) patient who has arginase deficiency 5) patient who has hepatic or renal failure within 3 months 6) patient who has cardiac infarction or has the history of cardiac infarction 7) patient who received the nitric-oxide related drug 2 week before their enrolment 8) patient who receive the steroid 14 days before enrolment 9) patient who is pregnant or possible to be pregnant 10) patient who has been enrolled to other clinical trial within 6 months. 11) patient whose enrolment is thought to be not adequate by responsible doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MELAS stroke scale | — |
Secondary
| Measure | Time frame |
|---|---|
| mitochondrial disease rating scale, MIDAS (migraine disability assessment scale) | — |
Countries
Japan
Contacts
Public ContactYasutoshi Koga
Kurume University
Outcome results
None listed