Home ALS Phase III ALS Trial “REFALS” Recruiting Patients

Phase III ALS Trial “REFALS” Recruiting Patients


Amyotrophic lateral levosimendan (ALS) is a rare and deadly disease with no known cure. The disease causes the death of motor neurons, ultimately evolving into paralysis. Death often occurs within 3-5 years of diagnosis—typically from respiratory failure. The objective of this study, sponsored by Orion Pharmaceuticals, is to test Levosimendan and its ability to maintain the patient’s breathing capability long and hence improve quality of life and also delay the need for ventilation support. ALS, a rare disease, with a reported incidence of one to two cases per 100,000 people. According to the Orion press release, ALS incidences by select country/region

United States                     16,800

Europe                                 12,500

TrialSite News includes a link to the study in ClinicalTrials.gov


Orion, the largest employer in the Finnish pharmaceutical industry, is the lead sponsor.  https://www.orion.fi/en/

Harvard is also involved as a investigative site.  The lead investigator is Merit E. Cudkowicz, MD


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