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

April 22, 2022 updated by: Orion Corporation, Orion Pharma
This study will evaluate whether prolonged oral levosimendan can preserve respiratory function more effectively than placebo, resulting in better patient functionality as measured by the ALSFRS-R scale. 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. The primary endpoint is slow vital capacity (SVC) at 12 weeks, with the impact on patient function assessed through 48 weeks, adjusted for patient outcome, using ALSFRS-R (combined assessment of function and survival, CAFS). Other important efficacy measures include time to respiratory events, clinical global impression (CGI), assessment of dyspnea using the Borg scale and sleep scales (Pittsburgh sleep quality index and Epworth sleepiness scale). Patient safety is monitored using conventional methods including adverse events, safety laboratory tests, vital signs and 12-lead EKG. Following screening and baseline visits, patients attend the clinic at 2, 4, 8, 12, 24, 36 and 48 weeks, with telephone assessments conducted at weeks 18, 30 and 42. An end of study visit is performed 14-25 days after the last study treatment administration. The study will be monitored by an independent data and safety monitoring board. A long-term extension study will be available for patients completing the study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
496

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Brain and Mind Centre
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Caulfield South, Victoria, Australia, 3162
        • Calvary Health Care Bethlehem
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Perron Institute for Neurological and Translational Science
  • Austria
      • Wien, Austria, 1090
        • Medizinische Universitat Wien
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Universität Innsbruck
    • Upper Austria
      • Vöcklabruck, Upper Austria, Austria, 4840
        • Salzkammergut-Klinikum Vöcklabruck
  • Belgium
    • Flemish Brabant
      • Leuven, Flemish Brabant, Belgium, 3000
        • Universitaire Ziekenhuis Leuven
    • Liege
      • Liège, Liege, Belgium, 4000
        • Centre Hospitalier Regional de la Citadelle
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Algemeen Ziekenhuis St. Lucas Gent
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3M 1M4
        • Alberta Health Services - Neuromuscular Clinic
      • Edmonton, Alberta, Canada, T6G 2G3
        • University of Alberta
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 0C7
        • Stan Cassidy Centre for Rehabilitation
      • Moncton, New Brunswick, Canada, E1C 2Z3
        • Moncton Hospital, Southeast Regional Health Authority
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster University Medical Centre
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
    • Quebec
      • Montréal, Quebec, Canada, H3A 2B4
        • Montreal Neurological Institute and Hospital
      • Montréal, Quebec, Canada, H2L 4M1
        • Centre De Recherche Du Centre Hospitalier de l'Universite de Montreal - Hopital Notre-Dame
      • Québec, Quebec, Canada, G1J 1Z4
        • Centre hospitalier affilié universitaire de Québec
  • Finland
      • Helsinki, Finland, 00029
        • Neurologian Poliklinikka - Meilahden Tornisairaala 3
      • Lappeenranta, Finland, 53130
        • Etela-Karjalan Keskussairaala
      • Turku, Finland, 20521
        • Turku University Hospital
  • France
      • Limoges, France, 87042
        • Centre Hospitalier Universitaire de Limoges
      • Montpellier, France, 34295
        • Hopital Gui de Chauliac
      • Nice, France, 06202
        • Hôpital Pasteur
      • Tours, France, 37044
        • Centre Hospitalier Régional et Universitaire de Tours Hôpital Bretonneau
  • Germany
      • Berlin, Germany, 13353
        • Charité Universitätsmedizin Berlin - Campus Virchow-Klinikum
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89081
        • Universitatsklinikum Ulm
    • Hessen
      • Wiesbaden, Hessen, Germany, 65191
        • Deutsche Klinik für Diagnostik
    • Mecklenburg-western-pommerania
      • Rostock, Mecklenburg-western-pommerania, Germany, 18147
        • Universitätsmedizin Rostock
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
    • Nordrhein-Westfalen
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • Universitatsklinikum Munster
    • Nordrhein-westfalen
      • Essen, Nordrhein-westfalen, Germany, 45131
        • Alfried Krupp Krankenhaus Rüttenscheid
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Universitatsklinikum Carl Gustav Carus
    • Thuringen
      • Jena, Thuringen, Germany, 07747
        • Universitätsklinikum Jena
  • Ireland
      • Dublin, Ireland, 9
        • Beaumont Hospital - Ireland
  • Italy
      • Genova, Italy, 16132
        • Azienda Ospedaliera Universitaria San Martino
      • Novara, Italy, 28100
        • Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara
      • Pavia, Italy, 27100
        • ICS Maugeri SpA SB
      • Pisa, Italy, 56126
        • Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
      • Roma, Italy, 0016
        • Policlinico Umberto i di Roma
      • Torino, Italy, 10126
        • Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino
  • Netherlands
      • Utrecht, Netherlands, 3584 CG
        • Universitair Medisch Centrum Utrecht - Rudolf Magnus Instituut voor Neurowetenschappen
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Academisch Medisch Centrum
  • Spain
      • Barcelona, Spain, 08207
        • Hospital Universitari de Bellvitge
      • Córdoba, Spain, 14011
        • Hospital Universitario Reina Sofia
      • Madrid, Spain, 28016
        • Hospital San Rafael - Madrid
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico de La Fe
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto
  • Sweden
      • Karlstad, Sweden, 651 85
        • Centralsjukhuset Karlstad
      • Stockholm, Sweden, 14186
        • Karolinska Universitetssjukhuset
    • Vasterbotten
      • Umeå, Vasterbotten, Sweden, 90737
        • Norrlands Universitetssjukhus
  • United Kingdom
      • Liverpool, United Kingdom, L9 7LJ
        • The Walton Centre NHS Foundation Trust
    • England
      • London, England, United Kingdom, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • London, England, United Kingdom, E1 1BB
        • Barts Health NHS Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Phoenix Neurological Associates
      • Phoenix, Arizona, United States, 85028
        • Neuromuscular Research Center and Neuromuscular Clinic of Arizona
    • California
      • La Jolla, California, United States, 92037-0886
        • University of California San Diego
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Orange, California, United States, 92868
        • University of California Irvine
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Colorado Springs Neurological Associates
    • Connecticut
      • New Britain, Connecticut, United States, 06053
        • Hospital for Special Care
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
      • Washington, District of Columbia, United States, 20037
        • The George Washington Medical Faculty Associates - Foggy Bottom North Pavilion
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Providence Holy Cross Medical Center
      • Gainesville, Florida, United States, 32611
        • University of Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
      • Jacksonville, Florida, United States, 32209
        • University of Florida Health - Jacksonville
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine
      • Augusta, Georgia, United States, 30912
        • Augusta University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University Feinberg School of Medicine
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Chandler Medical Center
      • Louisville, Kentucky, United States, 40202
        • Kentucky Neuroscience Research
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • The Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 49007
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
      • Saint Paul, Minnesota, United States, 55130-5302
        • HealthPartners Specialty Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Neurology Associates
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • New York, New York, United States, 10032
        • Columbia Presbyterian Hospital
      • New York, New York, United States, 10003
        • Mount Sinai Beth Israel
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Neurosciences Institute - Neurology Charlotte
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27157-1023
        • Wake Forest University Baptist Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97201-3098
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97213
        • Providence Brain and Spine Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University School of Medicine
      • Philadelphia, Pennsylvania, United States, 19107
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Dallas, Texas, United States, 75214
        • Texas Neurology
      • Houston, Texas, United States, 77030
        • Nerve And Muscle Center Of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah - Imaging & Neurosciences Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont Medical Center
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
      • Seattle, Washington, United States, 98122
        • Swedish Neuroscience Institute
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 116 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written or verbal informed consent (IC) for participation in the study
  • Male or female subjects with 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 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

Exclusion Criteria:

  • Subject in whom other causes of neuromuscular weakness have not been excluded
  • Subject with a diagnosis of another neurodegenerative disease (e.g. Parkinson's or Alzheimer's disease)
  • Assisted ventilation of any type within 3 months before the screening visit or at screening
  • Any use of a diaphragm pacing system (DPS) within 3 months before the screening visit
  • Any form of stem cell or gene therapy for the treatment of ALS
  • Known hypersensitivity to levosimendan
  • Administration of levosimendan within 3 months before the screening visit or previous participation in the present phase III study or earlier study with oral levosimendan in ALS patients (LEVALS)
  • Any use of tirasemtiv or reldesemtiv within 1 month before the screening visit.
  • Participation in a clinical trial with any experimental treatment within 30 days or within 5 half-lives of that treatment (whichever is longer) before the screening visit
  • Any botulinum toxin use within 3 months before the screening visit
  • Recorded diagnosis or evidence of major psychiatric diagnosis, significant cognitive impairment or clinically evident dementia that may interfere with the patient's ability to comply with study procedures
  • Pulmonary illness (e.g. asthma or COPD) requiring regular treatment
  • Haemodynamically significant uncorrected valve disease or hypertrophic cardiomyopathy or restrictive cardiomyopathy
  • Any cardiovascular event (e.g. myocardial infarction, HF, arrhythmia or stroke) requiring hospitalisation within 3 months before the screening visit
  • History of Torsades de Pointes (TdP) or diagnosed long QT-syndrome
  • History of life-threatening ventricular arrhythmia, unless treated with reliable measures to prevent recurrence (e.g. with placement of implantable cardioverter defibrillator [ICD] or catheter ablation)
  • History of second or third degree atrioventricular (AV) block or sinus node disease at screening, if not treated with pacemaker
  • HR repeatedly > 100 bpm in the 12-lead ECG after a 5-minute rest at screening. If the HR is > 100 bpm in the first recording, then the second recording must be done after another 5 min rest to confirm HR > 100 bpm
  • Systolic blood pressure (SBP) < 90 mmHg at screening
  • Potassium < 3.7 mmol/l or > 5.5 mmol/l at screening
  • Severe renal impairment (creatinine clearance < 30 ml/min at screening), creatinine > 170 μmol/l at screening or on dialysis
  • Blood haemoglobin < 10 g/dl at screening or blood donation or loss of significant amount of blood within 60 days before the screening visit
  • Clinically significant hepatic impairment at the discretion of the investigator
  • Body mass index (BMI) ≤ 18.5kg/m2 (BMI = weight/height2)
  • Women who are lactating or of reproductive age without a negative pregnancy test and without a commitment to using a highly effective method of contraception (e.g. oral hormonal contraceptives associated with inhibition of ovulation, intrauterine devices and long acting progestin agents), 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
  • Patient judged to be actively suicidal by the investigator during 3 months before the screening visit
  • Patients with known history of human immunodeficiency virus (HIV) infection
  • Any other clinically 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Levosimendan
Levosimendan 1 mg capsules for oral administration, once to twice a day. The total duration of treatment 48 weeks
Drug: Levosimendan
Levosimendan 1 mg capsule for oral administration
Other Names:
  • ODM-109
Placebo Comparator: Placebo for levosimendan
Placebo capsule for oral administration, once to twice a day. The total duration of treatment 48 weeks.
Drug: Placebo for levosimendan
Placebo capsule for oral administration
Other Names:
  • Placebo for ODM-109

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Supine Slow Vital Capacity (SVC)
Time Frame: The change from baseline at 12 weeks
Change from baseline to 12 weeks, expressed as % of predicted normal.
The change from baseline at 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Combined Assessment of Function and Survival Through 48 Weeks
Time Frame: Mean rank at 48 weeks
Scale: The ALS Functional Rating Scale - Revised. This scale includes 12 items. Each item was scored from 0 to 4. Total score is the sum of the scores of all 12 items. Each subject is ranked according to time-to-death (earlier deaths ranked lower than later deaths). Subjects who survive are ranked more favorably than subjects who died. Among the survivors, subjects are ranked according to change in ALSFRS-R (greater worsening of ALSFRS-R is ranked lower than after deaths). Subjects who survive are ranked more favorably than subjects who died. Among the survivors, subjects are ranked according to change in ALSFRS-R (greater worsening of ALSFRS-R is ranked lower than less worsening or an improvement in ALSFRS-R). The ranked scores range from 001 to 496 (the number of participants assessed for the Outcome Measure) with larger rank score numbers associated with a better outcome.
Mean rank at 48 weeks
Time to Respiratory Event Through 48 Weeks
Time Frame: Time to event through 48 weeks
ALSFRS-R scale contains 3 items that relate to respiratory function: severity of dyspnoea, occurrence of orthopnoea (shortness of breath when lying flat) and the use of mechanical ventilation for respiratory insufficiency. A reduction in any one of these items was considered a respiratory event. Not all patients receive ventilatory support, despite respiratory insufficiency: meeting "protocolised" criteria for NIV relates to patients without NIV whose slow vital capacity declined to a level that would ordinarily trigger such treatment.
Time to event through 48 weeks
Change From the Baseline in Clinical Global Impression CGI at 48 Weeks
Time Frame: The change from baseline at 48 weeks
Visual Analogue Scale 0-100 millimeters, rated by study subjects. Score 0 indicates that the subject is completely well without any disability and score 100 indicates the worst possible severity of the condition.
The change from baseline at 48 weeks
Change From Baseline in Respiratory Function of ALSFRS-R at 48 Weeks
Time Frame: Slope of decline at 48 weeks
ALSFRS-R scale contains 3 items that relate to respiratory function: severity of dyspnoea, occurrence of orthopnoea (shortness of breath when lying flat) and the use of mechanical ventilation for respiratory insufficiency. These are added together to created the respiratory domain with a score range 0-12 (where 12 represents normal function). Although individual items and patients vary, ALSFRS-R typically declines at a relatively constant rate over time. Plotted over time the slope of the line obtained indicates the speed of progression and thus an effective treatment might be expected to reduce the slope of decline.
Slope of decline at 48 weeks
Supine Borg Category Ratio 10 Scale at 12 Weeks
Time Frame: Change from baseline at 12 weeks
Patients rated their perception of the severity of their dysnoea using the Borg scale. The scale ranges from 0 (no dyspnoea) to 10 (maximal). Each category is numbered and most (not all) have verbal cues. At each assessment the patient scored the category they felt best described their symptoms. The analysis measured change from baseline at 12 weeks, where a negative score indicates improvement and a positive score reflects worsening.
Change from baseline at 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Orion Corporation, Orion Pharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Merja Mäkitalo, CSD, Orion Corporation, Orion Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 21, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 23, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 23, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3119002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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