Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension
NCT ID: NCT03948178
Last Updated: 2023-03-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
227 participants
INTERVENTIONAL
2019-06-26
2020-11-18
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Levosimendan
Oral Levosimendan; Levosimendan 1mg capsules for oral administration, once to twice a day, continued as long as clinically beneficial. The total study duration is up to 3 years.
Levosimendan
Levosimendan 1 mg capsule for oral administration
Interventions
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Levosimendan
Levosimendan 1 mg capsule for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
120 Years
ALL
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Geneviève Nadeau, CSD
Role: STUDY_DIRECTOR
Orion Corporation, Orion Pharma
Locations
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Neuromuscular research Centre and Neuromuscular Clinic of Arizona
Phoenix, Arizona, United States
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
Providence Brain and Spine Institute
Portland, Oregon, United States
Alleghenay General hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Nerve and Muscle Centre of Texas
Houston, Texas, United States
University of Utah Health-Imaging & Neurosciences Center in research Park
Salt Lake City, Utah, United States
University of Washington Medical Center
Seattle, Washington, United States
Brain and Mind Centre
Camperdown, New South Wales, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Calvary Health Care Bethlehem
Parkdale, Victoria, Australia
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia, Australia
Medizinische Universitat Innsbruck
Innsbruck, Tyrol, Austria
Salzqammergut-klinikum Vocklabruck, Neurologie
Vöcklabruck, Upper Austria, Austria
Medizinische Universitat wein Universitatsklinik ffur Neurologie
Wein, , Austria
Algemeen Ziekenhuis St Lucas Gent
Ghent, , Belgium
Universitair Ziekenhuis Leuven
Leuven, , Belgium
Centre Hospitalier Regional de la Vitadelle
Liège, , Belgium
Alberta Health Services-Neuromuscular Clinic
Calgary, Alberta, Canada
University of Alberta, Division of Neurology
Edmonton, Alberta, Canada
Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Centre Hospitalier Affilie Universitaire de Quebec
Québec, Quebec, Canada
Helsinki University Central Hospital, Neurology Outpatients Clinic
Helsinki, , Finland
Turku University Hospital
Turku, , Finland
Centre Hospitalier Universitaire de Limoges Service de Neurologie
Limoges, , France
Hopital Gui de Chauliac Service de Neurologie
Montpellier, , France
Hopital Pasteur Centre de reference des Malades Neuromusculaires et SLA
Nice, , France
Charite Universitatmedizin Berlin- Campus Virchow-Klinikum
Berlin, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitatsklinikum Jena, Klinik fur Neurologie
Jena, , Germany
Universitatsklinikum Munster, Institut fur Schalfmedizin und Neuromuskalaire Erkrankungen
Münster, , Germany
Universitatsmedizin Rostock, Klinik und Poliklinik fuer Neurologie
Rostock, , Germany
Universitatsklinikum Ulm, Poliklinik fur Neurologie
Ulm, , Germany
Deutsche Klinik fur Daignostik
Wiesbaden, , Germany
Beaumont Hospital, Clinical Research Centre
Dublin, , Ireland
Azienda Policlinico San Martino
Genova, , Italy
ICS Maugeri Spa S UO Riabilitazione Nurologica
Milan, , Italy
Azienda Ospedaliera Universitaria-maggiore della Carita di Novara
Novara, , Italy
Azienda Ospedaliero Universitaria Pisana Ospedale Santa Chiara
Pisa, , Italy
Policlinico Umberto I di Roma Clinica Neurologica
Rome, , Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
Torino, , Italy
Univeritair Medisch Centrum Utrech
Utrecht, , Netherlands
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Universitario de Basurto
Bilbao, , Spain
Hospital Universitario Reina Sofia Servicio Neurologia
Córdoba, , Spain
Hospital San Rafael
Madrid, , Spain
Hospital Universitario y Politecnico de La Fe
Valencia, , Spain
Karlstad Central Hospital Neurology and Rehabilitation
Karlstad, , Sweden
Karolinska University Horpital Huddinge Neurology Clinic
Stockholm, , Sweden
Norrlanda University Hospital Neuro-huvud-hals-centrum Vasterbotten
Umeå, , Sweden
The Walton Centre NHs Foundation Trust, Neurology and Neurosurgery
Liverpool, , United Kingdom
Barts Health NHS Trust Royal London hospital
London, , United Kingdom
Countries
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References
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Cudkowicz M, Genge A, Maragakis N, Petri S, van den Berg L, Aho VV, Sarapohja T, Kuoppamaki M, Garratt C, Al-Chalabi A; REFALS investigators. Safety and efficacy of oral levosimendan in people with amyotrophic lateral sclerosis (the REFALS study): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet Neurol. 2021 Oct;20(10):821-831. doi: 10.1016/S1474-4422(21)00242-8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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3119003
Identifier Type: -
Identifier Source: org_study_id
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