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A Study for Patients Who Completed VITALITY-ALS (CY 4031) (VIGOR-ALS)

Primary Purpose

Amyotrophic Lateral Sclerosis (ALS)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tirasemtiv
Sponsored by
Cytokinetics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amyotrophic Lateral Sclerosis (ALS) focused on measuring Amyotrophic Lateral Sclerosis, ALS, tirasemtiv

Eligibility Criteria

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

Inclusion Criteria:

  • Able to comprehend and willing to sign an Informed Consent Form (ICF). If verbal consent is given, a Legal Designee of the patient must sign the ICF form
  • Completed participation on study drug and the Follow-Up Visit in the CY 4031 study

  • Male patients, who have not had a vasectomy AND confirmed zero sperm count, must agree for the duration of their participation in the study to either:

    • Use a condom during sexual intercourse with female partners who are of childbearing potential AND to have female partners use a highly effective means of contraception OR
    • Abstain from sexual intercourse during participation in the study

  • Female patients who are not post-menopausal (≥ 1 year) or sterilized, must:

    • Not be breastfeeding
    • Have a negative pregnancy test
    • Have no intention to become pregnant during participation in the study AND
    • Practice sexual abstinence, defined as refraining from intercourse during the duration of the study OR if male partners are not vasectomized with a confirmed zero sperm count, require use of a condom AND use of a highly effective contraceptive measure

Exclusion Criteria:

  • Has a diaphragm pacing system (DPS) at study entry or anticipate DPS placement during the course of the study
  • Has taken an investigational study drug (other than tirasemtiv) prior to dosing, within 30 days or five half-lives of the prior agent, whichever is greater
  • Use of tizanidine and theophylline-containing medications during study participation
  • Participation or planning to participate in any form of stem cell therapy for the treatment of ALS or another investigational drug

Sites / Locations

  • St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
  • Cedars-Sinai Medical Center
  • University of California, Irvine
  • UC Davis Medical Center
  • Forbes Norris MDA/ALS Research Center
  • Stanford Hospital and Clinics
  • University of Colorado Hospital Anschutz Outpatient Pavilion
  • Hospital for Special Care
  • George Washington University Medical Center
  • Mayo Clinic
  • University of Miami, Miller School of Medicine
  • Carol & Frank Morsani Center for Advanced Health Care - University of South Florida
  • The Emory Clinic
  • Indiana University
  • University of Iowa Hospitals and Clinics
  • University of Kansas Medical Center
  • Johns Hopkins University
  • University of Massachusetts Memorial Medical Center/University of Massachusetts Medical School
  • University of Michigan Health System
  • Henry Ford Health System
  • Hennepin County Medical Center
  • St. Louis University, Department of Neurology & Psychiatry
  • Barnes-Jewish Hospital
  • Dartmouth Hitchcock Medical Center
  • Hospital for Special Surgery
  • Neurological Institute
  • SUNY Upstate Medical University
  • Neurosciences Institute, Neurology - Charlotte
  • Duke Neurological Disorders Clinic
  • Department of Neurology, Wake Forest School of Medicine
  • The Ohio State University Wexner Medical Center
  • Providence Brain and Spine Inst. ALS Center
  • Penn State Milton S. Hershey Medical Center
  • Temple University School of Medicine
  • Vanderbilt University Medical Center - Clinical Research Center
  • Texas Neurology, PA
  • UTHSCSA - First Outpatient Research Unit
  • University of Virginia Health System
  • University of Washington Medical Center
  • West Virginia University Hospitals
  • Froedtert Memorial Lutheran Hospital
  • UZ Leuven
  • University of Calgary
  • University of Alberta
  • Stan Cassidy Centre for Rehabilitation
  • QE II Health Sciences, Nova Scotia Health Authority
  • McMaster University Medical Centre
  • London Health Sciences Centre
  • Sunnybrook Health Sciences Center
  • Hopital Notre-Dame/CHUM
  • Montreal Neurological Institute and Hospital
  • CHU de Quebec - Univerite' Laval
  • Hopital Dupuytren, service de neurologie
  • Hopital Gui de chauliac
  • CHU de Nice - Hopital Pasteur 2
  • Hopital Bretonneau
  • University of Ulm, Department of Neurology
  • Hannover Medical School, Department of Neurology
  • Charite Campus Virchow-Klinikum, Department of Neurology
  • Clinical Research Centre Beaumont Hospital
  • IRCCS Istituto Auxologico Italiano - U.O. Neurologia
  • Centro Clinico NEMO - Fondazione Serena Onlus, ASST Grande Ospedale Metropolitano Niguarda, Ospedale Niguarda
  • Dipartimento di Neuroscienze "Rita Levi Moltalcini" A.O.U. Citta della Salute e della Scienza di Torino P.O. "Molinette"
  • University Medical Center Utrecht
  • Hospital Santa Maria - Centro Hospitalar Lisboa Norte
  • Hospital San Rafael
  • King's College Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Delayed Start Treatment

Early Start Treatment

Arm Description

The Delayed Start Treatment group consisted of patients who received placebo in CY 4031 and tirasemtiv in CY 4033.

The Early Start Treatment group consisted of patients who received tirasemtiv in both CY 4031 and CY 4033.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
The number of participants with adverse events was used as the measure for the long-term safety and tolerability of tirasemtiv.

Secondary Outcome Measures

Change From CY 4031 Baseline in Percent Predicted Slow Vital Capacity to Week 24 in CY 4033
Slow vital capacity (SVC) was measured using a spirometer (in units of liters). Following 3 to 5 breaths at rest, patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs). Values obtained were converted to percent predicted values (ie, the test result as a percent of predicted values for patients of similar demographic and baseline characteristics [eg, height, age, sex]).
Change From CY 4031 Baseline in Percent Predicted Slow Vital Capacity to Week 48 in CY 4033
Slow vital capacity was measured using a spirometer (in units of liters). Following 3 to 5 breaths at rest, patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs). Values obtained were converted to percent predicted values (ie, the test result as a percent of predicted values for patients of similar demographic and baseline characteristics [eg, height, age, sex]).
Change From CY 4031 Baseline in ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score at Week 24
The ALSFRS-R is used to measure the progression and severity of disability in patients with ALS. The ALSFRS-R consists of 12 questions, assessing a patient's capability and independence in functional activities relevant to ALS, categorized in the following 4 domains: gross motor tasks, fine motor tasks, bulbar functions, and respiratory function. Each question is scored from 0 (indicating incapable or dependent) to 4 (normal). The total score ranges from 0 to 48, with higher scores reflecting more normal function and lower scores reflecting more impaired function. Comparing postbaseline to baseline assessments, a negative value indicates a worsening in function.
Change From CY 4031 Baseline in ALSFRS-R Total Score at Week 48
The ALSFRS-R is used to measure the progression and severity of disability in patients with ALS. The ALSFRS-R consists of 12 questions, assessing a patient's capability and independence in functional activities relevant to ALS, categorized in the following 4 domains: gross motor tasks, fine motor tasks, bulbar functions, and respiratory function. Each question is scored from 0 (indicating incapable or dependent) to 4 (normal). The total score ranges from 0 to 48, with higher scores reflecting more normal function and lower scores reflecting more impaired function. Comparing postbaseline to baseline assessments, a negative value indicates a worsening in function.

Full Information

First Posted
October 12, 2016
Last Updated
May 27, 2021
Sponsor
Cytokinetics
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1. Study Identification

Unique Protocol Identification Number
NCT02936635
Brief Title
A Study for Patients Who Completed VITALITY-ALS (CY 4031)
Acronym
VIGOR-ALS
Official Title
A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients With Amyotrophic Lateral Sclerosis (ALS) Who Completed VITALITY-ALS (CY 4031)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 17, 2016 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cytokinetics

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS who had completed the double-blind placebo-controlled study of tirasemtiv in ALS (CY 4031).
Detailed Description
Enrolled participants will begin dosing of tirasemtiv 125 mg twice daily (250 mg/day) for a period of 4 weeks and will titrate to their tolerated dose, the maximum dose being 250 mg twice daily (500 mg/day). This study will also compare the clinical course of patients who completed treatment with tirasemtiv in CY 4031 with those who completed treatment with placebo in CY 4031 during continued treatment of both groups with tirasemtiv during CY 4033, compare the clinical course of patients who completed treatment with tirasemtiv in CY 4031 during that study with their clinical course during continued treatment with tirasemtiv during CY 4033, and compare the clinical course of patients who completed treatment with placebo in CY 4031 during that study with their clinical course during treatment with tirasemtiv during CY 4033.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis (ALS)
Keywords
Amyotrophic Lateral Sclerosis, ALS, tirasemtiv

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Delayed Start Treatment
Arm Type
Experimental
Arm Description
The Delayed Start Treatment group consisted of patients who received placebo in CY 4031 and tirasemtiv in CY 4033.
Arm Title
Early Start Treatment
Arm Type
Experimental
Arm Description
The Early Start Treatment group consisted of patients who received tirasemtiv in both CY 4031 and CY 4033.
Intervention Type
Drug
Intervention Name(s)
tirasemtiv
Other Intervention Name(s)
CK-2017357
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
The number of participants with adverse events was used as the measure for the long-term safety and tolerability of tirasemtiv.
Time Frame
From the first dose of tirasemtiv through 28 days after the last dose
Secondary Outcome Measure Information:
Title
Change From CY 4031 Baseline in Percent Predicted Slow Vital Capacity to Week 24 in CY 4033
Description
Slow vital capacity (SVC) was measured using a spirometer (in units of liters). Following 3 to 5 breaths at rest, patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs). Values obtained were converted to percent predicted values (ie, the test result as a percent of predicted values for patients of similar demographic and baseline characteristics [eg, height, age, sex]).
Time Frame
baseline and 24 weeks
Title
Change From CY 4031 Baseline in Percent Predicted Slow Vital Capacity to Week 48 in CY 4033
Description
Slow vital capacity was measured using a spirometer (in units of liters). Following 3 to 5 breaths at rest, patients were instructed to take as deep an inspiration as possible followed by a maximum exhalation (blowing out all the air in their lungs). Values obtained were converted to percent predicted values (ie, the test result as a percent of predicted values for patients of similar demographic and baseline characteristics [eg, height, age, sex]).
Time Frame
baseline and 48 weeks
Title
Change From CY 4031 Baseline in ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score at Week 24
Description
The ALSFRS-R is used to measure the progression and severity of disability in patients with ALS. The ALSFRS-R consists of 12 questions, assessing a patient's capability and independence in functional activities relevant to ALS, categorized in the following 4 domains: gross motor tasks, fine motor tasks, bulbar functions, and respiratory function. Each question is scored from 0 (indicating incapable or dependent) to 4 (normal). The total score ranges from 0 to 48, with higher scores reflecting more normal function and lower scores reflecting more impaired function. Comparing postbaseline to baseline assessments, a negative value indicates a worsening in function.
Time Frame
baseline and 24 weeks
Title
Change From CY 4031 Baseline in ALSFRS-R Total Score at Week 48
Description
The ALSFRS-R is used to measure the progression and severity of disability in patients with ALS. The ALSFRS-R consists of 12 questions, assessing a patient's capability and independence in functional activities relevant to ALS, categorized in the following 4 domains: gross motor tasks, fine motor tasks, bulbar functions, and respiratory function. Each question is scored from 0 (indicating incapable or dependent) to 4 (normal). The total score ranges from 0 to 48, with higher scores reflecting more normal function and lower scores reflecting more impaired function. Comparing postbaseline to baseline assessments, a negative value indicates a worsening in function.
Time Frame
baseline and 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Able to comprehend and willing to sign an Informed Consent Form (ICF). If verbal consent is given, a Legal Designee of the patient must sign the ICF form Completed participation on study drug and the Follow-Up Visit in the CY 4031 study Male patients, who have not had a vasectomy AND confirmed zero sperm count, must agree for the duration of their participation in the study to either: Use a condom during sexual intercourse with female partners who are of childbearing potential AND to have female partners use a highly effective means of contraception OR Abstain from sexual intercourse during participation in the study Female patients who are not post-menopausal (≥ 1 year) or sterilized, must: Not be breastfeeding Have a negative pregnancy test Have no intention to become pregnant during participation in the study AND Practice sexual abstinence, defined as refraining from intercourse during the duration of the study OR if male partners are not vasectomized with a confirmed zero sperm count, require use of a condom AND use of a highly effective contraceptive measure Exclusion Criteria: Has a diaphragm pacing system (DPS) at study entry or anticipate DPS placement during the course of the study Has taken an investigational study drug (other than tirasemtiv) prior to dosing, within 30 days or five half-lives of the prior agent, whichever is greater Use of tizanidine and theophylline-containing medications during study participation Participation or planning to participate in any form of stem cell therapy for the treatment of ALS or another investigational drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD, Cytokinetics
Organizational Affiliation
Cytokinetics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
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
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Forbes Norris MDA/ALS Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
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
Hospital for Special Care
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06053
Country
United States
Facility Name
George Washington University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami, Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Carol & Frank Morsani Center for Advanced Health Care - University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33512
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
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
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
University of Massachusetts Memorial Medical Center/University of Massachusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
University of Michigan Health System
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
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
St. Louis University, Department of Neurology & Psychiatry
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
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
Neurological Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Neurosciences Institute, Neurology - Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Duke Neurological Disorders Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Department of Neurology, Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
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
Providence Brain and Spine Inst. ALS Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Temple University School of Medicine
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, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
UTHSCSA - First Outpatient Research Unit
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Froedtert Memorial Lutheran Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
Stan Cassidy Centre for Rehabilitation
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 0C7
Country
Canada
Facility Name
QE II Health Sciences, Nova Scotia Health Authority
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
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
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Hopital Notre-Dame/CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
CHU de Quebec - Univerite' Laval
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Hopital Dupuytren, service de neurologie
City
Limoges Cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Gui de chauliac
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nice - Hopital Pasteur 2
City
Nice Cedex 1
ZIP/Postal Code
06001
Country
France
Facility Name
Hopital Bretonneau
City
Tours cedex 9
ZIP/Postal Code
37044
Country
France
Facility Name
University of Ulm, Department of Neurology
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Hannover Medical School, Department of Neurology
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
Facility Name
Charite Campus Virchow-Klinikum, Department of Neurology
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Clinical Research Centre Beaumont Hospital
City
Dublin
ZIP/Postal Code
Dublin 9
Country
Ireland
Facility Name
IRCCS Istituto Auxologico Italiano - U.O. Neurologia
City
Milan
State/Province
Lombardy
ZIP/Postal Code
20149
Country
Italy
Facility Name
Centro Clinico NEMO - Fondazione Serena Onlus, ASST Grande Ospedale Metropolitano Niguarda, Ospedale Niguarda
City
Milan
State/Province
Lombardy
ZIP/Postal Code
20162
Country
Italy
Facility Name
Dipartimento di Neuroscienze "Rita Levi Moltalcini" A.O.U. Citta della Salute e della Scienza di Torino P.O. "Molinette"
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Hospital Santa Maria - Centro Hospitalar Lisboa Norte
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Hospital San Rafael
City
Madrid
ZIP/Postal Code
28016
Country
Spain
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Study for Patients Who Completed VITALITY-ALS (CY 4031)

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