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
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Levosimendan
Placebo:
No
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
Geneviève Nadeau, CSD, Orion Corporation, Orion Pharma
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Boston, Massachusetts, United States
Study Sponsor:
Orion Corporation, Orion Pharma
Estimated Enrollment:
227
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?
Yes
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
Australia
Royal Brisbane and Women's Hospital
Herston, Queensland
4029
Australia
Flinders Medical Centre
Bedford Park, South Australia
5042
Australia
Calvary Health Care Bethlehem
Parkdale, Victoria
3195
Australia
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia
6009
Australia
Medizinische Universitat Innsbruck
Innsbruck, Tyrol
6020
Austria
Salzqammergut-klinikum Vocklabruck, Neurologie
Vocklabruck, Upper Austria
4840
Austria
Medizinische Universitat wein Universitatsklinik ffur Neurologie
Wein 1090
Austria
Algemeen Ziekenhuis St Lucas Gent
Gent 9000
Belgium
Universitair Ziekenhuis Leuven
Leuven 3000
Belgium
Centre Hospitalier Regional de la Vitadelle
Liège 4000
Belgium
Alberta Health Services-Neuromuscular Clinic
Calgary, Alberta
T3M 1M4
Canada
University of Alberta, Division of Neurology
Edmonton, Alberta
T6G 2G3
Canada
Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick
E3B 0C7
Canada
McMaster University Medical Centre
Hamilton, Ontario
L8N 3Z5
Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario
M4N 3M5
Canada
Montreal Neurological Institute and Hospital
Montréal, Quebec
H3A 2B4
Canada
Centre Hospitalier Affilie Universitaire de Quebec
Québec, Quebec
G1J 1Z4
Canada
Helsinki University Central Hospital, Neurology Outpatients Clinic
Helsinki 00029
Finland
Turku University Hospital
Turku 20521
Finland
Centre Hospitalier Universitaire de Limoges Service de Neurologie
Limoges
France
Hopital Gui de Chauliac Service de Neurologie
Montpellier 34295
France
Hopital Pasteur Centre de reference des Malades Neuromusculaires et SLA
Nice 06202
France
Charite Universitatmedizin Berlin- Campus Virchow-Klinikum
Berlin 13353
Germany
Medizinische Hochschule Hannover
Hannover 30625
Germany
Universitatsklinikum Jena, Klinik fur Neurologie
Jena 07747
Germany
Universitatsklinikum Munster, Institut fur Schalfmedizin und Neuromuskalaire Erkrankungen
Münster 48149
Germany
Universitatsmedizin Rostock, Klinik und Poliklinik fuer Neurologie
Rostock 18147
Germany
Universitatsklinikum Ulm, Poliklinik fur Neurologie
Ulm 89081
Germany
Deutsche Klinik fur Daignostik
Wiesbaden 65191
Germany
Beaumont Hospital, Clinical Research Centre
Dublin
Ireland
Azienda Policlinico San Martino
Genova 16132
Italy
ICS Maugeri Spa S UO Riabilitazione Nurologica
Milan 20138
Italy
Azienda Ospedaliera Universitaria-maggiore della Carita di Novara
Novara 28100
Italy
Azienda Ospedaliero Universitaria Pisana Ospedale Santa Chiara
Pisa 56126
Italy
Policlinico Umberto I di Roma Clinica Neurologica
Rome 00161
Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino 10126
Italy
Univeritair Medisch Centrum Utrech
Utrecht 3584
Netherlands
Hospital Universitari de Bellvitge
Barcelona 08207
Spain
Hospital Universitario de Basurto
Bilbao 48013
Spain
Hospital Universitario Reina Sofia Servicio Neurologia
Córdoba 14011
Spain
Hospital San Rafael
Madrid 28016
Spain
Hospital Universitario y Politecnico de La Fe
Valencia 46026
Spain
Karlstad Central Hospital Neurology and Rehabilitation
Karlstad
Sweden
Karolinska University Horpital Huddinge Neurology Clinic
Stockholm 14186
Sweden
Norrlanda University Hospital Neuro-huvud-hals-centrum Vasterbotten
Umeå 90185
Sweden
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