Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002

Study Purpose:

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.

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis

Study Type:


Type of Intervention:


Intervention Name:





Phase 3

Study Chair(s)/Principal Investigator(s):

Geneviève Nadeau, CSD, Orion Corporation, Orion Pharma

Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

Boston, Massachusetts, United States

Study Sponsor:

Orion Corporation, Orion Pharma

Estimated Enrollment:


Estimated Study Start Date:

06 / 26 / 2019

Estimated Study Completion Date:

11 / 18 / 2020

Posting Last Modified Date:

03 / 09 / 2023

Date Study Added to neals.org:

05 / 13 / 2019

Minimum Age:

18 Years

Maximum Age:

120 Years

Can participants use Riluzole?


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Neuromuscular research Centre and Neuromuscular Clinic of Arizona

Phoenix, Arizona 85028
United States

University of California San Diego

La Jolla, California 92037-0886
United States

University of California Irvine Medical Center

Orange, California 92868
United States

Hospital for Special Care

New Britain, Connecticut 06053
United States

Georgetown University

Washington, District of Columbia 20007
United States

The George Washington Medical Faculty Associates

Washington, District of Columbia 20037
United States

Holy Cross Hospital Neuroscience Institute

Fort Lauderdale, Florida 33308
United States

University of Florida McKnight Brain Institute

Gainesville, Florida 32611
United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224
United States

University of South Florida/USF Health

Tampa, Florida 33612
United States

Augusta University, Medical Centre

Augusta, Georgia 30912
United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois 60611
United States

University of Chicago

Chicago, Illinois 60637
United States

Johns Hopkins Hospital

Baltimore, Maryland 21287
United States

Massachusetts General Hospital

Boston, Massachusetts 02114
United States

University of Michigan, Michigan Medicine University Hospital

Ann Arbor, Michigan 48109
United States

Health Partners Speciality Center

Saint Paul, Minnesota 55130-5302
United States

Washington University School of Medicine

Saint Louis, Missouri 63110
United States

Neurology Associates

Lincoln, Nebraska 68506
United States

Hospital for Special Surgery

New York, New York 10021
United States

Columbia Presbyterian Hospital

New York, New York 10032
United States

Neurosciences Institute - Neurology Charlotte

Charlotte, North Carolina 28207
United States

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina 27157-1023
United States

The Ohio State University Wexner Medical center

Columbus, Ohio 43210
United States

Oregon Health and Science University

Portland, Oregon 97201-3098
United States

Providence Brain and Spine Institute

Portland, Oregon 97213
United States

Alleghenay General hospital

Pittsburgh, Pennsylvania 15212
United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania 15213
United States

Nerve and Muscle Centre of Texas

Houston, Texas 77030
United States

University of Utah Health-Imaging & Neurosciences Center in research Park

Salt Lake City, Utah 84132
United States

University of Washington Medical Center

Seattle, Washington 98195
United States

Brain and Mind Centre

Camperdown, New South Wales 2050

Flinders Medical Centre

Bedford Park, South Australia 5042

Calvary Health Care Bethlehem

Parkdale, Victoria 3195

Perron Institute for Neurological and Translational Science

Nedlands, Western Australia 6009

Royal Brisbane and Women's Hospital

Herston, Queensland 4029

Medizinische Universitat Innsbruck

Innsbruck, Tyrol 6020

Salzqammergut-klinikum Vocklabruck, Neurologie

Vocklabruck, Upper Austria 4840

Medizinische Universitat wein Universitatsklinik ffur Neurologie

Wein 1090

Algemeen Ziekenhuis St Lucas Gent

Gent 9000

Universitair Ziekenhuis Leuven

Leuven 3000

Centre Hospitalier Regional de la Vitadelle

Liège 4000

Sunnybrook Health Sciences Centre

Toronto, Ontario M4N 3M5

Centre Hospitalier Affilie Universitaire de Quebec

Québec, Quebec G1J 1Z4

Montreal Neurological Institute and Hospital

Montréal, Quebec H3A 2B4

Stan Cassidy Centre for Rehabilitation

Fredericton, New Brunswick E3B 0C7

McMaster University Medical Centre

Hamilton, Ontario L8N 3Z5

University of Alberta, Division of Neurology

Edmonton, Alberta T6G 2G3

Alberta Health Services-Neuromuscular Clinic

Calgary, Alberta T3M 1M4

Helsinki University Central Hospital, Neurology Outpatients Clinic

Helsinki 00029

Turku University Hospital

Turku 20521

Centre Hospitalier Universitaire de Limoges Service de Neurologie


Hopital Gui de Chauliac Service de Neurologie

Montpellier 34295

Hopital Pasteur Centre de reference des Malades Neuromusculaires et SLA

Nice 06202

Universitatsmedizin Rostock, Klinik und Poliklinik fuer Neurologie

Rostock 18147

Deutsche Klinik fur Daignostik

Wiesbaden 65191

Universitatsklinikum Ulm, Poliklinik fur Neurologie

Ulm 89081

Medizinische Hochschule Hannover

Hannover 30625

Universitatsklinikum Munster, Institut fur Schalfmedizin und Neuromuskalaire Erkrankungen

Münster 48149

Universitatsklinikum Jena, Klinik fur Neurologie

Jena 07747

Charite Universitatmedizin Berlin- Campus Virchow-Klinikum

Berlin 13353

Beaumont Hospital, Clinical Research Centre


Azienda Policlinico San Martino

Genova 16132

ICS Maugeri Spa S UO Riabilitazione Nurologica

Milan 20138

Azienda Ospedaliera Universitaria-maggiore della Carita di Novara

Novara 28100

Azienda Ospedaliero Universitaria Pisana Ospedale Santa Chiara

Pisa 56126

Policlinico Umberto I di Roma Clinica Neurologica

Rome 00161

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Torino 10126

Univeritair Medisch Centrum Utrech

Utrecht 3584

Hospital Universitari de Bellvitge

Barcelona 08207

Hospital Universitario de Basurto

Bilbao 48013

Hospital Universitario Reina Sofia Servicio Neurologia

Córdoba 14011

Hospital San Rafael

Madrid 28016

Hospital Universitario y Politecnico de La Fe

Valencia 46026

Karlstad Central Hospital Neurology and Rehabilitation


Karolinska University Horpital Huddinge Neurology Clinic

Stockholm 14186

Norrlanda University Hospital Neuro-huvud-hals-centrum Vasterbotten

Umeå 90185

The Walton Centre NHs Foundation Trust, Neurology and Neurosurgery

Liverpool L9 7LJ
United Kingdom

Barts Health NHS Trust Royal London hospital

London E1 1BB
United Kingdom