Back to resultsA Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS) (COURAGE-ALS)
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Reldesemtiv
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, ALS, CK-2127107, Reldesemtiv, COURAGE-ALS
Eligibility Criteria
Key Inclusion Criteria:
- Males or Females between the ages of 18 and 80 years of age, inclusive
- Diagnosis of familial or sporadic ALS (defined as meeting the laboratory-supported probable, probable, or definite criteria for ALS according to the World Federation of Neurology El Escorial criteria). Patients who meet the possible criteria are eligible if they have lower motor neuron findings; those who have purely upper motor neuron findings are ineligible.
- First symptom of ALS ≤ 24 months prior to screening. The qualifying first symptoms of ALS are limited to manifestations of weakness in extremity, bulbar, or respiratory muscles.
- ALSFRS-R total score ≤ 44 at screening. Patients with a total score of 45 or higher may be rescreened 60±7 days following the original screening date.
- Upright FVC ≥ 65.0% of predicted for age, height, sex and ethnicity at screening according to Global Lung Initiative equation
- Must be either on riluzole for ≥ 30 days prior to screening or have not taken it for at least 30 days prior to screening
- Must have completed at least 2 cycles of edaravone at the time of screening or have not received it for at least 30 days prior to screening
- Able to swallow whole tablets
Exclusion Criteria:
- eGFRCysC < 45.0 mL/min/1.73 m2 at screening
- Urine protein/creatinine ratio > 1 mg/mg (113 mg/mmol) at screening
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3-times the upper limit of normal (ULN)
- Total bilirubin (TBL), direct or indirect bilirubin above the ULN.
- Cognitive impairment, related to ALS or otherwise that impairs the patient's ability to understand and/or comply with study procedures and provide informed consent
- Other medically significant neurological conditions that could interfere with the assessment of ALS symptoms, signs or progression.
- Has a tracheostomy
Sites / Locations
- St. Joseph's Hospital & Medical Center - Barrow Neurological Institute
- Cedars-Sinai Medical Center
- University of California Irvine - ALS & Neuromuscular Center
- California Pacific Medical Center - Forbes Norris MDA/ALS Research Center
- Stanford Hospital and Clinics
- University of Colorado Hospital Anschutz Outpatient Pavilion
- GW Medical Faculty Associates
- University of Florida Jacksonville
- Mayo Clinic Florida
- University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
- Duchossois Center for Advanced Medicine
- Indiana University
- University of Iowa Hospitals and Clinics
- The University of Kansas Medical Center
- Johns Hopkins Outpatient Center
- Massachusetts General Hospital - Neurological Clinical Research Institute
- University of Massachusetts Memorial Medical Center/Medical School
- Michigan Medicine
- Henry Ford Health System
- Washington University School of Medicine - Center for Advance Medicine
- Neurology Associates, PC
- Hospital for Special Surgery
- Columbia University Medical Center
- University of Rochester Medical Center
- SUNY Upstate Medical University
- Atrium Health Neuroscience Institute - Charlotte
- Cleveland Clinic
- Providence ALS Center
- Oregon Health and Science University
- Penn State Health Milton S. Hershey Medical Center
- Lewis Katz School of Medicine at Temple University
- Vanderbilt University Medical Center - Clinical Research Center
- Texas Neurology, P.A.
- University of Vermont Medical Center
- VCU Neuroscience Orthopaedic and Wellness Center (NOW)
- Froedtert Hospital
- Brain and Mind Centre
- Concord Repatriation General Hospital
- Royal Brisbane and Women's Hospital
- Flinders Medical Centre
- The Perron Institute
- UZ Leuven Gasthuisberg, Department of Neurology
- University of Calgary - Heritage Medical Research Clinic
- University of Alberta
- Stan Cassidy Centre for Rehabilitation
- McMaster University Medical Centre
- London Health Sciences Centre
- Ottawa Hospital Research Institute - Civic Campus
- Sunnybrook Research Institute
- Centre de recherche du CHUM
- McGill University, Montreal Neurological Institute & Hospital
- CHU de Quebec-Université Laval
- Saskatoon City Hospital
- Deparment of Neurology Bispebjerg University Hospital
- CRC SLA de Lyon
- CHRU de Lille Hopital Roger Salengro
- CHU de Limoges - Hopital Dupuytren
- CHU de la Timone
- CHU de Nice - Hôpital Pasteur 2
- Hopital La Pitie Salpetriere
- CHRU de Tours, Hopital Bretonneau, Clinical Research Center
- Charité - Universitätsmedizin Berlin
- Universitatsklinikum Bonn
- Medical School Hannover - Department of Neurology
- Universitatsklinikum Jena
- Universitätsklinikum Schleswig Holstein
- Universitatsklinikum Ulm
- RSCI Education and Research Centre, Beaumont Hospital
- Instituti Clinici Scientifici Maugeri
- Ospedale San Luca
- Centro Clinical Nemo - Fondazione Serena Onlus
- AOU Città della Salute e Scienza (Molinette),
- UMC Utrecht, Department of Neurology, ALS Center
- City Clinic Research
- Centro Hospitalar Universitario Lisboa Norte, Department of Neurology
- Hospital Universitari de Bellvitge
- Hospital Universitario Basurto
- Hospital San Rafael
- Hospital Universitari i Politecnic La Fe
- Neurologimottagningen Skane University Hospital
- Studieenheten Akademiskt Specialistcentrum, Sabbatsberg Hospital
- Muskelzentrum/ALS Clinic
- The Walton Centre NHS Foundation Trust
- Maurice Wohl Clinical Neuroscience Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Experimental
Arm Label
300 mg reldesemtiv twice daily for a 600 mg total daily dose, from Day 1 until Week 24
Placebo twice daily, from Day 1 until Week 24
300 mg reldesemtiv twice daily for a 600 mg total daily dose, from Week 24 until Week 48
150 mg reldesemtiv twice daily for a 300 mg total daily dose, from Week 24 until Week 48
Arm Description
Patients in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Patients in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Patients in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48 for patients who were not down titrated during the 24 weeks of blinded dosing.
Patients in this arm take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48 for patients who were down titrated for any reason during the 24 weeks of blinded dosing.
Outcomes
Primary Outcome Measures
Effect of reldesemtiv versus placebo on functional outcomes in ALS
Change from baseline to Week 24 in ALS Functional Rating Scale-Revised (ALSFRS-R) total score; rating scale 0 to 48; higher scores indicate better functional status
Secondary Outcome Measures
Effect of reldesemtiv versus placebo on combined functional and survival outcomes in ALS
Combined assessment of change in ALSFRS-R total score, time to onset of respiratory insufficiency, and survival time up to Week 24. In this joint rank test each individual patient is ranked compared to all other patients based on survival time, time to onset of respiratory insufficiency, and changes from baseline to Week 24 in ALSFRS-R total score. Deaths have the worst rank (with earlier deaths being ranked worse than later deaths); patients with onset of respiratory insufficiency have the next worst rank; and the more favorable changes from baseline at week 24 in ALSFRS-R total score have the best rank using this process.
Effect of reldesemtiv versus placebo on ventilatory function
Change from baseline to Week 24 in the percent predicted FVC
Effect of reldesemtiv versus placebo on quality of life
Change from baseline to Week 24 in the ALS Assessment Questionnaire-40 (ALSAQ-40) total score; rating scale 0 to 100; higher scores indicate worse quality of life
Effect of reldesemtiv versus placebo on handgrip strength
Change from baseline to Week 24 in handgrip strength (average of both hands)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04944784
Brief Title
A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)
Acronym
COURAGE-ALS
Official Title
A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
The DMC recommended the trial be discontinued due to futility following a planned second interim analysis.
Study Start Date
August 16, 2021 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytokinetics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.
Detailed Description
COURAGE-ALS is a Phase 3, double-blind, randomized, placebo-controlled trial of reldesemtiv in patients aged 18 to 80 with ALS.
The screening and qualification period for the trial will be no more than 14 days in duration. Approximately 555 eligible ALS patients will be randomized (2:1) to receive the following dose of reldesemtiv or placebo (stratified by riluzole use/non-use and edaravone use/non-use) for the first 24 weeks (double-blind, placebo-controlled period):
300 mg reldesemtiv twice a day for a 600 mg total daily dose (TDD)
Placebo twice daily
At the end of the 24-week double-blind, placebo-controlled period, patients will transition to the active drug period, where all patients will receive the following dose of reldesemtiv for the next 24 weeks:
300 mg reldesemtiv twice a day for a 600 mg TDD for patients who were not down titrated during the 24 weeks of blinded dosing
150 mg reldesemtiv twice a day for a 300 mg TDD for patients who were down titrated during the 24 weeks of blinded dosing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, ALS, CK-2127107, Reldesemtiv, COURAGE-ALS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
486 (Actual)
8. Arms, Groups, and Interventions
Arm Title
300 mg reldesemtiv twice daily for a 600 mg total daily dose, from Day 1 until Week 24
Arm Type
Experimental
Arm Description
Patients in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Day 1 until Week 24.
Arm Title
Placebo twice daily, from Day 1 until Week 24
Arm Type
Placebo Comparator
Arm Description
Patients in this arm take 2 placebo oral tablets twice a day from Day 1 until Week 24.
Arm Title
300 mg reldesemtiv twice daily for a 600 mg total daily dose, from Week 24 until Week 48
Arm Type
Experimental
Arm Description
Patients in this arm take 2 reldesemtiv 150 mg oral tablets twice a day for a 600 mg total daily dose from Week 24 until Week 48 for patients who were not down titrated during the 24 weeks of blinded dosing.
Arm Title
150 mg reldesemtiv twice daily for a 300 mg total daily dose, from Week 24 until Week 48
Arm Type
Experimental
Arm Description
Patients in this arm take 1 reldesemtiv 150 mg oral tablet twice a day for a 300 mg total daily dose from Week 24 until Week 48 for patients who were down titrated for any reason during the 24 weeks of blinded dosing.
Intervention Type
Drug
Intervention Name(s)
Reldesemtiv
Intervention Description
Reldesemtiv Oral Tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Oral Tablet
Primary Outcome Measure Information:
Title
Effect of reldesemtiv versus placebo on functional outcomes in ALS
Description
Change from baseline to Week 24 in ALS Functional Rating Scale-Revised (ALSFRS-R) total score; rating scale 0 to 48; higher scores indicate better functional status
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Effect of reldesemtiv versus placebo on combined functional and survival outcomes in ALS
Description
Combined assessment of change in ALSFRS-R total score, time to onset of respiratory insufficiency, and survival time up to Week 24. In this joint rank test each individual patient is ranked compared to all other patients based on survival time, time to onset of respiratory insufficiency, and changes from baseline to Week 24 in ALSFRS-R total score. Deaths have the worst rank (with earlier deaths being ranked worse than later deaths); patients with onset of respiratory insufficiency have the next worst rank; and the more favorable changes from baseline at week 24 in ALSFRS-R total score have the best rank using this process.
Time Frame
24 Weeks
Title
Effect of reldesemtiv versus placebo on ventilatory function
Description
Change from baseline to Week 24 in the percent predicted FVC
Time Frame
Baseline to Week 24
Title
Effect of reldesemtiv versus placebo on quality of life
Description
Change from baseline to Week 24 in the ALS Assessment Questionnaire-40 (ALSAQ-40) total score; rating scale 0 to 100; higher scores indicate worse quality of life
Time Frame
Baseline to Week 24
Title
Effect of reldesemtiv versus placebo on handgrip strength
Description
Change from baseline to Week 24 in handgrip strength (average of both hands)
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Males or Females between the ages of 18 and 80 years of age, inclusive
Diagnosis of familial or sporadic ALS (defined as meeting the laboratory-supported probable, probable, or definite criteria for ALS according to the World Federation of Neurology El Escorial criteria). Patients who meet the possible criteria are eligible if they have lower motor neuron findings; those who have purely upper motor neuron findings are ineligible.
First symptom of ALS ≤ 24 months prior to screening. The qualifying first symptoms of ALS are limited to manifestations of weakness in extremity, bulbar, or respiratory muscles.
ALSFRS-R total score ≤ 44 at screening. Patients with a total score of 45 or higher may be rescreened 60±7 days following the original screening date.
Upright FVC ≥ 65.0% of predicted for age, height, sex and ethnicity at screening according to Global Lung Initiative equation
Must be either on riluzole for ≥ 30 days prior to screening or have not taken it for at least 30 days prior to screening
Must have completed at least 2 cycles of edaravone at the time of screening or have not received it for at least 30 days prior to screening
Able to swallow whole tablets
Exclusion Criteria:
eGFRCysC < 45.0 mL/min/1.73 m2 at screening
Urine protein/creatinine ratio > 1 mg/mg (113 mg/mmol) at screening
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3-times the upper limit of normal (ULN)
Total bilirubin (TBL), direct or indirect bilirubin above the ULN.
Cognitive impairment, related to ALS or otherwise that impairs the patient's ability to understand and/or comply with study procedures and provide informed consent
Other medically significant neurological conditions that could interfere with the assessment of ALS symptoms, signs or progression.
Has a tracheostomy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cytokinetics, MD
Organizational Affiliation
Cytokinetics
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California Irvine - ALS & Neuromuscular Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
California Pacific Medical Center - Forbes Norris MDA/ALS Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Hospital Anschutz Outpatient Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
GW Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
University of Florida Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of South Florida - Carol and Frank Morsani Center for Advanced Health Care
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Duchossois Center for Advanced Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital - Neurological Clinical Research Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center/Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Michigan Medicine
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School of Medicine - Center for Advance Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Neurology Associates, PC
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 University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Atrium Health Neuroscience Institute - Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Providence ALS Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Lewis Katz School of Medicine at Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Vanderbilt University Medical Center - Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Texas Neurology, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
VCU Neuroscience Orthopaedic and Wellness Center (NOW)
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Brain and Mind Centre
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
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
The Perron Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
UZ Leuven Gasthuisberg, Department of Neurology
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University of Calgary - Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
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
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Ottawa Hospital Research Institute - Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Centre de recherche du CHUM
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
Facility Name
McGill University, Montreal Neurological Institute & Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
CHU de Quebec-Université Laval
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Saskatoon City Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0M7
Country
Canada
Facility Name
Deparment of Neurology Bispebjerg University Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
Facility Name
CRC SLA de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHRU de Lille Hopital Roger Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de Limoges - Hopital Dupuytren
City
Limoges
ZIP/Postal Code
87 042
Country
France
Facility Name
CHU de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU de Nice - Hôpital Pasteur 2
City
Nice
ZIP/Postal Code
06 001
Country
France
Facility Name
Hopital La Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHRU de Tours, Hopital Bretonneau, Clinical Research Center
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitatsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Medical School Hannover - Department of Neurology
City
Hanover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitatsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitätsklinikum Schleswig Holstein
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Universitatsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
RSCI Education and Research Centre, Beaumont Hospital
City
Beaumont
State/Province
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
Instituti Clinici Scientifici Maugeri
City
Milano
ZIP/Postal Code
20138
Country
Italy
Facility Name
Ospedale San Luca
City
Milan
ZIP/Postal Code
20149
Country
Italy
Facility Name
Centro Clinical Nemo - Fondazione Serena Onlus
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
AOU Città della Salute e Scienza (Molinette),
City
Turin
ZIP/Postal Code
10126
Country
Italy
Facility Name
UMC Utrecht, Department of Neurology, ALS Center
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
City Clinic Research
City
Warsaw
ZIP/Postal Code
02-473
Country
Poland
Facility Name
Centro Hospitalar Universitario Lisboa Norte, Department of Neurology
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital San Rafael
City
Madrid
ZIP/Postal Code
28016
Country
Spain
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Neurologimottagningen Skane University Hospital
City
Malmö
ZIP/Postal Code
21428
Country
Sweden
Facility Name
Studieenheten Akademiskt Specialistcentrum, Sabbatsberg Hospital
City
Stockholm
ZIP/Postal Code
11361
Country
Sweden
Facility Name
Muskelzentrum/ALS Clinic
City
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
The Walton Centre NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7LJ
Country
United Kingdom
Facility Name
Maurice Wohl Clinical Neuroscience Institute
City
London
ZIP/Postal Code
SE5 9RX
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)
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