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This was an open label extension for patients completing the REFALS study (3119002; NCT03505021). Study 3119002 showed lack of efficacy of ODM109 so the sponsor decided to terminate this study
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levosimendan | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levosimendan | Drug | Levosimendan 1 mg capsule for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Recording | Adverse Events as subject counts and proportions (%) of subject per Adverse Event | From signing informed consent until 14-25 days after the last study treatment for all patients, an average of 23.5 weeks. |
| Pulse/Heart Rate Assessment | Actual values and changes from baseline in supine pre-dose pulse/heart rate were summarised using descriptive statistics . | Change in pulse and heart rate(from ECG recording) from Baseline, week 2, week 4, week 6 (pulse rate only), Month 3, Month 6, end of study (subject's last visit, 2-48 weeks after study entry) |
| 12-lead Electrocardiogram Assessments | Summarisation of any abnormal 12-lead ECG findings using descriptive statistics. | Baseline, week 2, week 4, month 3, month 6, end-of-study(subject's last visit, 2-48 weeks after study entry) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Progression | Count of study withdrawals due to disease progression | From Baseline through study completion(subject's last visit, 2-48 weeks after study entry) |
| Supine Slow Vital Capacity (SVC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geneviève Nadeau, CSD | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuromuscular research Centre and Neuromuscular Clinic of Arizona | Phoenix | Arizona | 85028 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34536404 | Derived | 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. |
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Male or female subjects with a diagnosis of probable or definite ALS having completed 48 weeks of treatment in the REFALS Study (NCT03505021) and able to swallow study treatment capsules at the time of completing 48 weeks of dosing in the REFALS study. Written or verbal informed consent obtained.
Patients with amyotrophic lateral sclerosis (ALS) who completed 48 weeks of treatment in the REFALS study (NCT03505021) were recruited
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 26, 2020 | May 24, 2022 |
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Change from baseline in supine and sitting SVC (all devices) through to the end of the study, expressed as a % of predicted normal
| The change from Baseline, week 2, week 4, month 3, month 6, end-of-study (subject's last visit, 2-48 weeks after study entry) |
| Revised ALS Functional Rating Scale (ALSFRS-R) | ALSFRS-R scale contains 3 parameters related to respiratory function: Severity of dyspnea, occurrence of orthopnea (shortness of breath when in supine position i.e. lying flat), and the use of mechanical ventilation for respiratory in sufficiency. These 3 parameters are combined to create the respiratory domain with a score of 0-12(where 12 is 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 ro reduce the slope of decline. | Change from Baseline in respiratory function of ALSFRS-R at study completion (subject's last visit, 2-48 weeks after study entry) |
| Need for Respiratory Support Device | Time to respiratory device support (non invasive) or death | Time to event at study completion (subject's last visit, 2-48 weeks after study entry) |
| Borg Category Ratio 10 Scale (CR 10) | Patients rated their perception of the severity of their dyspnea using the Borg Category Ration 10 scale (CR 10). The scale ranges from 0(no dysponea) to 10 (maximal dyspnea). each category is numbered and most but 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 to the end of the study in both a supine and sitting position where a negative score indicates improvement and a positive score reflects worsening. | Baseline through study completion (week 2, week 4, month 3, month 6, end of study (subject's last visit, 2-48 weeks after study entry) |
| Number of Subjects Requiring Health and Home Care Resource Use | The number of study subjects requiring Health and home care resource use was aggregated over the course of the study for each subject and summarised using descriptive statistics. | Baseline through study completion (2- 48 weeks after study entry) |
| Subject's Status for Tracheostomy and Survival | Number of patients with the need for tracheostomy or who died whilst on treatment from baseline to the end of the study was summarised using descriptive statistics. | Baseline to end of study (average 2-48 weeks after study entry |
| Health Care Service Use During the Study(Stays in Hospital) | The number of night stays in hospital were recorded throughout the study using a diary given to the study subjects | From baseline to the end of the study(2-48 weeks after study entry) |
| Health Care Service Use During the Study(Visits to the Emergency Room) | The number of visits to the emergency room were recorded throughout the study using a diary given to the study subjects | From baseline to the end of the study(2-48 weeks after study entry) |
| Health Care Service Use During the Study (Days Spent in an Institutional Facility) | The number of days spent in an institutional facility were recorded throughout the study using a diary given to the study subjects | From baseline to the end of the study(2-48 weeks after study entry) |
| 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 D.C. | District of Columbia | 20007 | United States |
| The George Washington Medical Faculty Associates | Washington D.C. | 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 | St 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 | Vöcklabruck | Upper Austria | 4840 | Austria |
| Medizinische Universitat wein Universitatsklinik ffur Neurologie | Wein | 1090 | Austria |
| Algemeen Ziekenhuis St Lucas Gent | Ghent | 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 | Montreal | 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 | Hanover | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intention-to-Treat (ITT) including all randomised subjects was used for the primary evaluation.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events Recording | Adverse Events as subject counts and proportions (%) of subject per Adverse Event | Analysis is reported for the safety population which included all subjects receiving any study treatment. Treatment emergent AEs are defined as any event arising or worsening after the start of study treatment until 25 days after the individual subject's last study treatment. | Posted | Count of Participants | Participants | From signing informed consent until 14-25 days after the last study treatment for all patients, an average of 23.5 weeks. |
|
|
| ||||||||||||||||||||||||||
| Primary | Pulse/Heart Rate Assessment | Actual values and changes from baseline in supine pre-dose pulse/heart rate were summarised using descriptive statistics . | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Change in pulse and heart rate(from ECG recording) from Baseline, week 2, week 4, week 6 (pulse rate only), Month 3, Month 6, end of study (subject's last visit, 2-48 weeks after study entry) |
|
| ||||||||||||||||||||||||||
| Primary | 12-lead Electrocardiogram Assessments | Summarisation of any abnormal 12-lead ECG findings using descriptive statistics. | Analysis of patients in the safety population defined as all patients who had received at least one dose of study treatment | Posted | Count of Participants | Participants | Baseline, week 2, week 4, month 3, month 6, end-of-study(subject's last visit, 2-48 weeks after study entry) |
|
| |||||||||||||||||||||||||||
| Secondary | Disease Progression | Count of study withdrawals due to disease progression | Number of study withdrawals due to disease progression were collected for all subjects entered into the study. The study sponsor terminated the study. | Posted | Count of Participants | Participants | From Baseline through study completion(subject's last visit, 2-48 weeks after study entry) |
|
| |||||||||||||||||||||||||||
| Secondary | Supine Slow Vital Capacity (SVC) | Change from baseline in supine and sitting SVC (all devices) through to the end of the study, expressed as a % of predicted normal | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | Posted | Mean | Standard Deviation | % of predicted normal | The change from Baseline, week 2, week 4, month 3, month 6, end-of-study (subject's last visit, 2-48 weeks after study entry) |
|
| ||||||||||||||||||||||||||
| Secondary | Revised ALS Functional Rating Scale (ALSFRS-R) | ALSFRS-R scale contains 3 parameters related to respiratory function: Severity of dyspnea, occurrence of orthopnea (shortness of breath when in supine position i.e. lying flat), and the use of mechanical ventilation for respiratory in sufficiency. These 3 parameters are combined to create the respiratory domain with a score of 0-12(where 12 is 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 ro reduce the slope of decline. | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | Posted | Mean | Standard Deviation | Score on a scale | Change from Baseline in respiratory function of ALSFRS-R at study completion (subject's last visit, 2-48 weeks after study entry) |
| |||||||||||||||||||||||||||
| Secondary | Need for Respiratory Support Device | Time to respiratory device support (non invasive) or death | Analyses were performed in the safety population in which all subjects received at least one dose of study treatment | Posted | Mean | Standard Error | days | Time to event at study completion (subject's last visit, 2-48 weeks after study entry) |
|
| ||||||||||||||||||||||||||
| Secondary | Borg Category Ratio 10 Scale (CR 10) | Patients rated their perception of the severity of their dyspnea using the Borg Category Ration 10 scale (CR 10). The scale ranges from 0(no dysponea) to 10 (maximal dyspnea). each category is numbered and most but 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 to the end of the study in both a supine and sitting position where a negative score indicates improvement and a positive score reflects worsening. | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | Posted | Mean | Standard Deviation | units on a scale | Baseline through study completion (week 2, week 4, month 3, month 6, end of study (subject's last visit, 2-48 weeks after study entry) |
| |||||||||||||||||||||||||||
| Secondary | Number of Subjects Requiring Health and Home Care Resource Use | The number of study subjects requiring Health and home care resource use was aggregated over the course of the study for each subject and summarised using descriptive statistics. | Posted | Count of Participants | Participants | Baseline through study completion (2- 48 weeks after study entry) |
|
| ||||||||||||||||||||||||||||
| Secondary | Subject's Status for Tracheostomy and Survival | Number of patients with the need for tracheostomy or who died whilst on treatment from baseline to the end of the study was summarised using descriptive statistics. | Analysis was performed on the safety population which includes all subjects receiving at least one dose of study treatment | Posted | Count of Participants | Participants | Baseline to end of study (average 2-48 weeks after study entry |
|
| |||||||||||||||||||||||||||
| Secondary | Health Care Service Use During the Study(Stays in Hospital) | The number of night stays in hospital were recorded throughout the study using a diary given to the study subjects | Analysis performed on the safety population defined as any subject receiving at least one dose of study treatment | Posted | Mean | Standard Deviation | Nights | From baseline to the end of the study(2-48 weeks after study entry) |
|
| ||||||||||||||||||||||||||
| Secondary | Health Care Service Use During the Study(Visits to the Emergency Room) | The number of visits to the emergency room were recorded throughout the study using a diary given to the study subjects | Analysis performed on the safety population defined as any subject receiving at least one dose of study treatment | Posted | Mean | Standard Deviation | visits | From baseline to the end of the study(2-48 weeks after study entry) |
|
| ||||||||||||||||||||||||||
| Secondary | Health Care Service Use During the Study (Days Spent in an Institutional Facility) | The number of days spent in an institutional facility were recorded throughout the study using a diary given to the study subjects | Analysis performed on the safety population defined as any subject receiving at least one dose of study treatment | Posted | Mean | Standard Deviation | days | From baseline to the end of the study(2-48 weeks after study entry) |
|
|
From signing informed consent until 14-25 days after the last study treatment administration, an average of 23.5 weeks.
Four enrolled subjects did not start study treatment and are excluded from the safety population
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 19 | 227 | 44 | 227 | 215 | 227 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysponea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cystitis bacterial | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Systemic Viral Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Intestinal Obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lower Intestinal Hemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Saliva altered | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Stoma Site Pain | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Subdural Hematoma | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Supraventricular Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Euthanesia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back Pain | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Invasive Ductal Breast Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Metastasis to lymph nodes | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Renal Mass | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oxygen Saturation decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysponea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Heart Rate Increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Compliance and UK Study Management, Clinical Operations | Orion Corporation | +441159487100 | clinicaltrials@orionpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2020 | May 24, 2022 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077464 | Simendan |
| ID | Term |
|---|---|
| D006835 | Hydrazones |
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D011724 | Pyridazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
|
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|