Effects of ODM-109 in ALS

Condition: Amyotrophic lateral sclerosis

Eligibility

Key Inclusion Criteria

  • At least 18 years old
  • Diagnosis of laboratory-supported probable, probable or definite ALS
  • Able to swallow study treatment capsules and is expected to continue to do so during the study

Key Exlusion Criteria

  • Subject in whom other causes of neuromuscular weakness have not been excluded
  • Diagnosis of another neurodegenerative disease
  • Assisted ventilation of any type within 3 months of the screening visit or at screening

Full Study Name

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multinational, Multicenter Study to Confirm That Levosimendan Can Significantly Improve Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS) (IRB no. 52583)

Phase

Phase III

Summary

The purpose of this study is to evaluate the safety of an investigational drug called levosimendan (ODM-109) in treating patients with ALS (amyotrophic lateral sclerosis) by measuring breathing function. Participants will be asked about their health status; the safety of the drug will be assessed by blood tests, medical examinations and documentation of the amount of care needed for the patient’s ALS. Previous studies have shown that levosimendan may be useful for improving the muscle strength of the diaphragm—and thereby the breathing function and overall well being—for patients with ALS. 

Principal Investigator

Matthew Burford, MD

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