Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS

Purpose

This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality. View more study details on ClinicalTrials.gov. 

Procedures

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. 

For more details about study procedures, please contact Camille Swartz:

Eligibility

  • Male or female subjects with a diagnosis of laboratory-supported probable, probable or definite ALS according to El Escorial revised criteria. Full electromyogram (EMG) report available consistent with ALS (but not necessarily fulfilling the electrodiagnostic criteria for ALS) from an experienced neurophysiologist
  • Able to swallow study treatment capsules, and in the opinion of the investigator, is expected to continue to do so during the study
  • Sitting SVC between 60-90% of the predicted value for age, height, and sex at the screening visit
  • Disease duration from symptom onset (defined by first muscle weakness or dysarthria) 12-48 months at the time of visit 1 (baseline)
  • Able to perform supine SVC in an adequate and reliable way at screening and baseline visits as judged by the investigator
  • Subjects with or without riluzole and/or edaravone. If using riluzole (any daily dose up to 100 mg), the dose must have been stable for at least 4 weeks before the screening visit and should not be changed during the study. If using edaravone, the treatment should have been started at least 4 weeks before the screening visit (at least one 28-day treatment cycle as indicated) and should not be changed during the study. If not on riluzole and/or edaravone, the respective treatments should not be started during the study

For more details about eligibility criteria, please contact Camille Swartz:

Age

18 to 65
65 and over

Gender

Male
Female

Can be done from home

No

Keywords

Amyotrophic lateral sclerosis, ALS - resources, ALS, Neurology

Principal Investigator

James Wymer, MD, PhD

Department

Neurology

Contact Information

cami.swartz@neurology.ufl.edu

352-273-5612


Be an Informed Participant

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Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
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