Effects of Oral Levosimendan on Respiratory Function in Patients With ALS: Open-Label Extension
Status:
Completed
Trial end date:
2020-11-18
Target enrollment:
Participant gender:
Summary
This study provides an opportunity for subjects in the REFALS (3119002; NCT03505021) study to
continue treatment with oral levosimendan. The study will also provide more information about
long-term safety and effectiveness of oral levosimendan in patients with ALS.
This is an open-label study, so that all eligible subjects that complete the double-blind
REFALS study (48-weeks of treatment) will have the opportunity to receive oral levosimendan
treatment. The primary objective, in addition to continuing treatment for subjects enrolled
in the REFALS study, is to evaluate long-term safety of oral levosimendan in ALS patients.
Another important objective is to explore long-term effectiveness of oral levosimendan in the
treatment of patients with ALS.
This study is open only to patients taking part in the REFALS study.