drugset / Trial / NCT01847651

Brain Muscle Axis During Treatment of Hepatic Encephalopathy With L-ornithine L-aspartate

NCT01847651

Phase 4 Completed 42 enrolled Imperial College London
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Patients with cirrhosis of the liver may suffer from a condition called hepatic encephalopathy which in its mildest form as mental slowing and impaired reaction times in driving and machinery operation. Left untreated it may lead to deep coma. The cause is not fully understood but is though to be related to the inability of a damaged liver to filter out toxins such as ammonia in the blood, which then accumulate within the brain and result in altered function and swelling within certain brain cells,astrocytes. These patients also suffer from muscle loss, which is associated with a poor outcome. L-ornithine L-aspartate(LOLA) is a licensed drug in Germany and has been shown to promote ammonia elimination from the body in the form of urea. Some experimental studies have suggested that LOLA also potentially attenuates muscle loss by incorporating ammonia into muscle in the form of glutamine. The aim of this study is to determine cognitive and nutritional effects of 12 weeks of LOLA administration and its effect on brain muscle structure and function in patients with cirrhosis.

Timeline

Start
2013-08
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator L-ornithine L-aspartate Other / unclassified 18 g