Researchers at Orion Pharma are looking for participants with ALS (amyotrophic lateral sclerosis) to participate in the REFALS Phase 3 study. The study is designed to help researchers evaluate the effects of oral levosimendan (ODM-109) on respiratory function in patients with ALS. Participants will be randomized to receive either levosimendan or placebo to determine whether treatment with levosimendan is associated with improved respiratory function.
Total study duration for each patient will be approximately 48 weeks, with eight clinic visits required. Drug efficacy will be evaluated by measuring respiratory function through slow vital capacity as well as assessing patient function using the ALS Functional Rating Scale Revised (ALSFRS-R). Throughout the study, participants will continue to see their regular doctor for routine care.
In order to be eligible to participate, individuals must:
- Be diagnosed with laboratory-supported probable, probable or definite ALS according to EL Escorial revised criteria
- Able to obtain a full electromyogram (EMG) report consistent with ALS
- Able to swallow treatment capsules throughout the duration of the study (evaluated by the investigator)
- Sitting SVC between 60 and 90 percent of the predicted value for age, height and gender
- Disease duration from symptom onset (defined by first muscle weakness or dysarthria) 12 to 48 months at the time of the first visit
- Able to perform supine SVC in an adequate and reliable way (evaluated by investigator at screening visit)
- Possibly be receiving treatment with riluzole and/or edaravone, but the dose must be stable at least four weeks prior to the screening visit and treatment may not be changed or started during the study
- Meet additional study criteria
To see if you qualify for the trial, click here.