Abstract Details

Title Investigator Mediated Phase III Open Labeled L-Arginine Clinical Trial at Acute Phase of Stroke-Like Episodes (SLE) in MELAS

Topic Interventional Neurology

Presentation(s) P07 - (-)

Poster/Presentation
Number 254

Objective

Background BACKGROUND: We reported that L-arginine was effective to improve the acute symptoms of SLE by intravenous infusion (Neurology 2002;58:827-828, Neurology 2005;64:710-771, Neurology 2006;66:1766-1769).

Design/Methods DESIGN/METHODS: Patients with MELAS having an A3243G mutation, who come to the hospital within 6 hours after the onset of SLE, were enrolled in this study. After getting IRB approval and informed consent, 5 ml/kg/dose of 10% L-arginine-HCl solution was infused and evaluated the clinical symptoms related to SLE. Primary outcome is the improvement of headache and nausea/vomit at 2 hours after the infusion, which evaluated by grading scale and visual analog scale (VAS). Secondary outcome is the improvement of headache, nausea/vomit, convulsion, unconsciousness and blindness at 2, 6, 12, 24 hours after the infusion.

Results RESULTS: Trial has been done in 9 institutions from June 2, 2008 to August 19, 2011 in Japan. Among 18 patients registered, 10 patients with 14 SLEs were enrolled, however 2 episodes has been terminated because of un-responsiveness. The headache and nausea/vomit were clearly improved by IV within 6, 12, 24 hours after infusion, however, there are no improvement within 2 hours after IV. In comparison, placebo in the previous study (Neurology 2005;64:710-771) does not show any improvements in these time periods.

Conclusions CONCLUSIONS: L-arginine infusion at the acute phase of SLE in MELAS showed improvement of headache and nausea/vomit, indicating that L-Arginine therapy showed promise in treating SLE in MELAS. L-arginine infusion within 2 hours after the onset of SLE showed the best outcome and prognosis in the acute phase of treatment.

Authors/Disclosures
Yasutoshi Koga, MD, PhD (Kurume University) PRESENTER	No disclosure on file
	No disclosure on file
Nataliya Povalko, MD, PhD (Kurume University)	No disclosure on file
	No disclosure on file
Ludwig Kappos, MD, FAAN (RC2NB, University Hospital Basel)	Dr. Kappos has nothing to disclose.

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