Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS
Status:
Completed
Trial end date:
2020-07-23
Target enrollment:
Participant gender:
Summary
This study will evaluate whether prolonged oral levosimendan can preserve respiratory
function more effectively than placebo, resulting in better patient functionality as measured
by the ALSFRS-R scale. In this randomized, double-blind, placebo-controlled, parallel-group,
multicenter study, subjects are allocated in a 2:1 ratio to receive either levosimendan (1 -2
mg daily) or placebo for 48 weeks. The primary endpoint is slow vital capacity (SVC) at 12
weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient
outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important
efficacy measures include time to respiratory events, clinical global impression (CGI),
assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index
and Epworth sleepiness scale). Patient safety is monitored using conventional methods
including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following
screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48
weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is
performed 14-25 days after the last study treatment administration. The study will be
monitored by an independent data and safety monitoring board. A long-term extension study
will be available for patients completing the study.