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

Investigator mediated Phase III open labeled L-arginine clinical trial on the acute phase of stroke-like episodes in MELAS - IIS-MELAS001

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2091220023
Enrollment
18
Registered
2008-11-19
Start date
2008-11-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mitochondrial myopathy (MELAS with an A3243G mutation)

Interventions

Intervention type:DRUG Name of intervention:L-arginine Dose form / Japanese Medical Device Nomenclature:INJECTION Route of administration / Site of application:INTRAVENOUS DRIP Dose per administration

Sponsors

Kurume University Yasutoshi Koga
Lead Sponsor
Hidefumi Nakamura, Clinical Trial Center, National Research Center of Pediatrics and Child Health, Japan
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: MELAS 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

Exclusion criteria

Exclusion criteria: 1) 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

Design outcomes

Primary

MeasureTime frame
headache, vomit

Secondary

MeasureTime frame
convulsion, unconsciousness, blindness

Countries

Japan

Contacts

Public ContactYasutoshi Koga

Kurume University

yasukoga@med.kurume-u.ac.jp+81-942-31-7565

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026