Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension

Stopped early · Phase 3

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT03948178

Run by

Orion Corporation, Orion Pharma

People needed

227

Starts

2019-06-26

Expected to finish

2020-11-18

Last updated by the study team

2023-03-09

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written or verbal informed consent (IC) for participation in the study
• Subjects who completed 48 weeks of treatment according to the REFALS study protocol
• Able to swallow study treatment capsules at the time of completing 48 weeks dosing in the REFALS study

You may not qualify if…

• Development (or significant worsening from baseline of the REFALS study) of serious cardiovascular disease (e.g.: myocardial infarction, heart failure, arrhythmia, stroke, or second or third degree atrioventricular (AV) block)
• Pulse/heart rate repeatedly >100 bpm after 5-minute rest at baseline. If the pulse/heart rate is >100 bpm in the first recording, then a second recording must be done after another 5 min rest to confirm pulse/heart rate >100 bpm
• Systolic blood pressure (SBP) <90 mmHg
• Severe renal impairment (creatinine clearance < 30ml/min or creatine >170 µmol/l at 48 week visit of the REFALS study, or on dialysis
• Severe hepatic impairment at the discretion of the investigator
• Women of reproductive age without a negative pregnancy test and without a commitment to using a highly effective method of contraception (e.g.: oral hormonal contraceptive associated with inhibition of ovulation, intrauterine devices and long acting progestin agent), if sexually active during the study, and for 1 month after the last dose of the study treatment. Women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be reproductive and can be included
• Subject judged to be actively suicidal by the investigator
• Any other clinical significant cardiovascular, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results or constitute a health risk for the subject if he/she took part in the study

Where it is running

• University of California San Diego — La Jolla, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Hospital for Special Care — New Britain, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• The George Washington Medical Faculty Associates — Washington D.C., District of Columbia, United States
• Holy Cross Hospital Neuroscience Institute — Fort Lauderdale, Florida, United States
• University of Florida McKnight Brain Institute — Gainesville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• University of South Florida/USF Health — Tampa, Florida, United States
• Augusta University, Medical Centre — Augusta, Georgia, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan, Michigan Medicine University Hospital — Ann Arbor, Michigan, United States
• Health Partners Speciality Center — Saint Paul, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Neurology Associates — Lincoln, Nebraska, United States
• Hospital for Special Surgery — New York, New York, United States
• Columbia Presbyterian Hospital — New York, New York, United States
• Neurosciences Institute - Neurology Charlotte — Charlotte, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• The Ohio State University Wexner Medical center — Columbus, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Neuromuscular research Centre and Neuromuscular Clinic of Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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