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Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension (REFALS-ES)

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levosimendan
Sponsored by
Orion Corporation, Orion Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neuromuscular research Centre and Neuromuscular Clinic of Arizona
  • University of California San Diego
  • University of California Irvine Medical Center
  • Hospital for Special Care
  • Georgetown University
  • The George Washington Medical Faculty Associates
  • Holy Cross Hospital Neuroscience Institute
  • University of Florida McKnight Brain Institute
  • Mayo Clinic Jacksonville
  • University of South Florida/USF Health
  • Augusta University, Medical Centre
  • Northwestern University Feinberg School of Medicine
  • University of Chicago
  • Johns Hopkins Hospital
  • Massachusetts General Hospital
  • University of Michigan, Michigan Medicine University Hospital
  • Health Partners Speciality Center
  • Washington University School of Medicine
  • Neurology Associates
  • Hospital for Special Surgery
  • Columbia Presbyterian Hospital
  • Neurosciences Institute - Neurology Charlotte
  • Wake Forest University Baptist Medical Center
  • The Ohio State University Wexner Medical center
  • Oregon Health and Science University
  • Providence Brain and Spine Institute
  • Alleghenay General hospital
  • University of Pittsburgh Medical Center
  • Nerve and Muscle Centre of Texas
  • University of Utah Health-Imaging & Neurosciences Center in research Park
  • University of Washington Medical Center
  • Brain and Mind Centre
  • Royal Brisbane and Women's Hospital
  • Flinders Medical Centre
  • Calvary Health Care Bethlehem
  • Perron Institute for Neurological and Translational Science
  • Medizinische Universitat Innsbruck
  • Salzqammergut-klinikum Vocklabruck, Neurologie
  • Medizinische Universitat wein Universitatsklinik ffur Neurologie
  • Algemeen Ziekenhuis St Lucas Gent
  • Universitair Ziekenhuis Leuven
  • Centre Hospitalier Regional de la Vitadelle
  • Alberta Health Services-Neuromuscular Clinic
  • University of Alberta, Division of Neurology
  • Stan Cassidy Centre for Rehabilitation
  • McMaster University Medical Centre
  • Sunnybrook Health Sciences Centre
  • Montreal Neurological Institute and Hospital
  • Centre Hospitalier Affilie Universitaire de Quebec
  • Helsinki University Central Hospital, Neurology Outpatients Clinic
  • Turku University Hospital
  • Centre Hospitalier Universitaire de Limoges Service de Neurologie
  • Hopital Gui de Chauliac Service de Neurologie
  • Hopital Pasteur Centre de reference des Malades Neuromusculaires et SLA
  • Charite Universitatmedizin Berlin- Campus Virchow-Klinikum
  • Medizinische Hochschule Hannover
  • Universitatsklinikum Jena, Klinik fur Neurologie
  • Universitatsklinikum Munster, Institut fur Schalfmedizin und Neuromuskalaire Erkrankungen
  • Universitatsmedizin Rostock, Klinik und Poliklinik fuer Neurologie
  • Universitatsklinikum Ulm, Poliklinik fur Neurologie
  • Deutsche Klinik fur Daignostik
  • Beaumont Hospital, Clinical Research Centre
  • Azienda Policlinico San Martino
  • ICS Maugeri Spa S UO Riabilitazione Nurologica
  • Azienda Ospedaliera Universitaria-maggiore della Carita di Novara
  • Azienda Ospedaliero Universitaria Pisana Ospedale Santa Chiara
  • Policlinico Umberto I di Roma Clinica Neurologica
  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
  • Univeritair Medisch Centrum Utrech
  • Hospital Universitari de Bellvitge
  • Hospital Universitario de Basurto
  • Hospital Universitario Reina Sofia Servicio Neurologia
  • Hospital San Rafael
  • Hospital Universitario y Politecnico de La Fe
  • Karlstad Central Hospital Neurology and Rehabilitation
  • Karolinska University Horpital Huddinge Neurology Clinic
  • Norrlanda University Hospital Neuro-huvud-hals-centrum Vasterbotten
  • The Walton Centre NHs Foundation Trust, Neurology and Neurosurgery
  • Barts Health NHS Trust Royal London hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levosimendan

Arm Description

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.

Outcomes

Primary Outcome Measures

Adverse Events Recording
Adverse Events as subject counts and proportions (%) of subject per Adverse Event
Pulse/Heart Rate Assessment
Actual values and changes from baseline in supine pre-dose pulse/heart rate were summarised using descriptive statistics .
12-lead Electrocardiogram Assessments
Summarisation of any abnormal 12-lead ECG findings using descriptive statistics.

Secondary Outcome Measures

Disease Progression
Count of study withdrawals due to disease progression
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
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.
Need for Respiratory Support Device
Time to respiratory device support (non invasive) or death
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.
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.
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.
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
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
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

Full Information

First Posted
May 7, 2019
Last Updated
February 9, 2023
Sponsor
Orion Corporation, Orion Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT03948178
Brief Title
Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension
Acronym
REFALS-ES
Official Title
Effects of Oral Levosimendan (ODM-109) on Respiratory Function in Patients With ALS: Open-Label Extension for Patients Completing Study 3119002
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
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
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
November 18, 2020 (Actual)
Study Completion Date
November 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orion Corporation, Orion Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
227 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levosimendan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Other Intervention Name(s)
ODM-109
Intervention Description
Levosimendan 1 mg capsule for oral administration
Primary Outcome Measure Information:
Title
Adverse Events Recording
Description
Adverse Events as subject counts and proportions (%) of subject per Adverse Event
Time Frame
From signing informed consent until 14-25 days after the last study treatment for all patients, an average of 23.5 weeks.
Title
Pulse/Heart Rate Assessment
Description
Actual values and changes from baseline in supine pre-dose pulse/heart rate were summarised using descriptive statistics .
Time Frame
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)
Title
12-lead Electrocardiogram Assessments
Description
Summarisation of any abnormal 12-lead ECG findings using descriptive statistics.
Time Frame
Baseline, week 2, week 4, month 3, month 6, end-of-study(subject's last visit, 2-48 weeks after study entry)
Secondary Outcome Measure Information:
Title
Disease Progression
Description
Count of study withdrawals due to disease progression
Time Frame
From Baseline through study completion(subject's last visit, 2-48 weeks after study entry)
Title
Supine Slow Vital Capacity (SVC)
Description
Change from baseline in supine and sitting SVC (all devices) through to the end of the study, expressed as a % of predicted normal
Time Frame
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)
Title
Revised ALS Functional Rating Scale (ALSFRS-R)
Description
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.
Time Frame
Change from Baseline in respiratory function of ALSFRS-R at study completion (subject's last visit, 2-48 weeks after study entry)
Title
Need for Respiratory Support Device
Description
Time to respiratory device support (non invasive) or death
Time Frame
Time to event at study completion (subject's last visit, 2-48 weeks after study entry)
Title
Borg Category Ratio 10 Scale (CR 10)
Description
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.
Time Frame
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)
Title
Number of Subjects Requiring Health and Home Care Resource Use
Description
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.
Time Frame
Baseline through study completion (2- 48 weeks after study entry)
Title
Subject's Status for Tracheostomy and Survival
Description
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.
Time Frame
Baseline to end of study (average 2-48 weeks after study entry
Title
Health Care Service Use During the Study(Stays in Hospital)
Description
The number of night stays in hospital were recorded throughout the study using a diary given to the study subjects
Time Frame
From baseline to the end of the study(2-48 weeks after study entry)
Title
Health Care Service Use During the Study(Visits to the Emergency Room)
Description
The number of visits to the emergency room were recorded throughout the study using a diary given to the study subjects
Time Frame
From baseline to the end of the study(2-48 weeks after study entry)
Title
Health Care Service Use During the Study (Days Spent in an Institutional Facility)
Description
The number of days spent in an institutional facility were recorded throughout the study using a diary given to the study subjects
Time Frame
From baseline to the end of the study(2-48 weeks after study entry)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geneviève Nadeau, CSD
Organizational Affiliation
Orion Corporation, Orion Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Neuromuscular research Centre and Neuromuscular Clinic of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037-0886
Country
United States
Facility Name
University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Hospital for Special Care
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06053
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
The George Washington Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Holy Cross Hospital Neuroscience Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida McKnight Brain Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of South Florida/USF Health
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Augusta University, Medical Centre
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan, Michigan Medicine University Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Health Partners Speciality Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130-5302
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Neurology Associates
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Columbia Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Neurosciences Institute - Neurology Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1023
Country
United States
Facility Name
The Ohio State University Wexner Medical center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201-3098
Country
United States
Facility Name
Providence Brain and Spine Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Alleghenay General hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Nerve and Muscle Centre of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah Health-Imaging & Neurosciences Center in research Park
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Brain and Mind Centre
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Calvary Health Care Bethlehem
City
Parkdale
State/Province
Victoria
ZIP/Postal Code
3195
Country
Australia
Facility Name
Perron Institute for Neurological and Translational Science
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Medizinische Universitat Innsbruck
City
Innsbruck
State/Province
Tyrol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Salzqammergut-klinikum Vocklabruck, Neurologie
City
Vocklabruck
State/Province
Upper Austria
ZIP/Postal Code
4840
Country
Austria
Facility Name
Medizinische Universitat wein Universitatsklinik ffur Neurologie
City
Wein
ZIP/Postal Code
1090
Country
Austria
Facility Name
Algemeen Ziekenhuis St Lucas Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Regional de la Vitadelle
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Alberta Health Services-Neuromuscular Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3M 1M4
Country
Canada
Facility Name
University of Alberta, Division of Neurology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
Stan Cassidy Centre for Rehabilitation
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 0C7
Country
Canada
Facility Name
McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Centre Hospitalier Affilie Universitaire de Quebec
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Helsinki University Central Hospital, Neurology Outpatients Clinic
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Centre Hospitalier Universitaire de Limoges Service de Neurologie
City
Limoges
Country
France
Facility Name
Hopital Gui de Chauliac Service de Neurologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Pasteur Centre de reference des Malades Neuromusculaires et SLA
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Charite Universitatmedizin Berlin- Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitatsklinikum Jena, Klinik fur Neurologie
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitatsklinikum Munster, Institut fur Schalfmedizin und Neuromuskalaire Erkrankungen
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitatsmedizin Rostock, Klinik und Poliklinik fuer Neurologie
City
Rostock
ZIP/Postal Code
18147
Country
Germany
Facility Name
Universitatsklinikum Ulm, Poliklinik fur Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Deutsche Klinik fur Daignostik
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Beaumont Hospital, Clinical Research Centre
City
Dublin
Country
Ireland
Facility Name
Azienda Policlinico San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
ICS Maugeri Spa S UO Riabilitazione Nurologica
City
Milan
ZIP/Postal Code
20138
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria-maggiore della Carita di Novara
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana Ospedale Santa Chiara
City
Pisa
ZIP/Postal Code
56126
Country
Italy
Facility Name
Policlinico Umberto I di Roma Clinica Neurologica
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Univeritair Medisch Centrum Utrech
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
08207
Country
Spain
Facility Name
Hospital Universitario de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario Reina Sofia Servicio Neurologia
City
Córdoba
ZIP/Postal Code
14011
Country
Spain
Facility Name
Hospital San Rafael
City
Madrid
ZIP/Postal Code
28016
Country
Spain
Facility Name
Hospital Universitario y Politecnico de La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Karlstad Central Hospital Neurology and Rehabilitation
City
Karlstad
Country
Sweden
Facility Name
Karolinska University Horpital Huddinge Neurology Clinic
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Name
Norrlanda University Hospital Neuro-huvud-hals-centrum Vasterbotten
City
Umeå
ZIP/Postal Code
90185
Country
Sweden
Facility Name
The Walton Centre NHs Foundation Trust, Neurology and Neurosurgery
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Barts Health NHS Trust Royal London hospital
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34536404
Citation
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.
Results Reference
derived

Learn more about this trial

Effects of Oral Levosimendan on Respiratory Function in Patients With Amyotrophic Lateral Sclerosis (ALS): Open-Label Extension

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