Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 32 n° 15

The 30th International Symposium on ALS/MND

Posted by fidest press agency su venerdì, 13 dicembre 2019

Orion has studied the effects of oral levosimendan on respiratory function in patients with ALS and presented biomarker and pharmacokinetic data from previous studies, a systematic literature review on pharmacological effects of levosimendan, and baseline characteristics and status update on the progression of REFALS phase 3 study at the 30th International Symposium on ALS/MND in Perth, Australia last week.
The REFALS trial studying the effects of oral levosimendan on respiratory function in patients with ALS, completed enrolment in July 2019. The trial enrolled 496 adult patients with definite, probable or laboratory supported probable ALS and some degree of respiratory dysfunction (sitting SVC 60-90%) at 104 clinical sites in 14 countries in EU, North America and Australia. Randomised patients are treated with oral levosimendan (target dose 2mg daily) or placebo for 48 weeks in a double-blind, parallel group design.Baseline characteristics of the patients enrolled in REFALS are similar to those of other recent large clinical trials in ALS. Due to inclusion criteria, all patients in REFALS study have already had signs of decrease in their respiratory function. The patients enrolled in REFALS were on average 59.3 years of age, 61.9% percent male, and had experienced symptoms more than 2 years and had substantial disability based on the ALS-FRS-R score. Most patients were receiving riluzole and almost one third of patients in North America had started edaravone. Safety labs revealed relatively common increases in liver tests, low creatinine and frequently increased markers of muscle injury including CRP, creatine kinase and troponin T.

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