REFALS phase III study
REFALS phase III study (Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS)
This study evaluates whether prolonged oral intake of levosimendan better preserves respiratory function than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. In this double-blind international study, patients either take levosimendan (1-2 mg daily) or placebo with a 2:1 chance for 48 weeks. Key inclusion criteria are slow vital capacity (SVC) between 60% -90% in sitting position and having ALS since 1 to 4 years. The primary endpoint is SVC at 12 weeks and the impact on functioning is assessed through 48 weeks. Other respiratory parameters, clinical global impression, shortness of breath and sleep are also measured. Patient safety is monitored via the usual methods including ECG. Patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments in between. For patients completing the study completely, a long-term extension study is possible. In Belgium, the academic centers in Ghent, Liège and Leuven take part.
Detailed information and the list of in-and exclusion criteria can be found at this link.