A Study for Patients Who Completed VITALITY-ALS (CY 4031)
VIGOR-ALS
A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients With Amyotrophic Lateral Sclerosis (ALS) Who Completed VITALITY-ALS (CY 4031)
2 other identifiers
interventional
280
11 countries
67
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2016
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 12, 2016
CompletedStudy Start
First participant enrolled
October 17, 2016
CompletedFirst Posted
Study publicly available on registry
October 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2018
CompletedResults Posted
Study results publicly available
May 12, 2021
CompletedJune 15, 2021
May 1, 2021
2 years
October 12, 2016
April 20, 2021
May 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
From the first dose of tirasemtiv through 28 days after the last dose
Secondary Outcomes (4)
Change From CY 4031 Baseline in Percent Predicted Slow Vital Capacity to Week 24 in CY 4033
baseline and 24 weeks
Change From CY 4031 Baseline in Percent Predicted Slow Vital Capacity to Week 48 in CY 4033
baseline and 48 weeks
Change From CY 4031 Baseline in ALS Functional Rating Scale - Revised (ALSFRS-R) Total Score at Week 24
baseline and 24 weeks
Change From CY 4031 Baseline in ALSFRS-R Total Score at Week 48
baseline and 48 weeks
Study Arms (2)
Delayed Start Treatment
EXPERIMENTALThe Delayed Start Treatment group consisted of patients who received placebo in CY 4031 and tirasemtiv in CY 4033.
Early Start Treatment
EXPERIMENTALThe Early Start Treatment group consisted of patients who received tirasemtiv in both CY 4031 and CY 4033.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cytokineticslead
Study Sites (67)
St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
Phoenix, Arizona, 85013, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California, Irvine
Orange, California, 92868, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Forbes Norris MDA/ALS Research Center
San Francisco, California, 94115, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado, 80045, United States
Hospital for Special Care
New Britain, Connecticut, 06053, United States
George Washington University Medical Center
Washington D.C., District of Columbia, 20037, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
University of Miami, Miller School of Medicine
Miami, Florida, 33136, United States
Carol & Frank Morsani Center for Advanced Health Care - University of South Florida
Tampa, Florida, 33512, United States
The Emory Clinic
Atlanta, Georgia, 30322, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
University of Massachusetts Memorial Medical Center/University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
St. Louis University, Department of Neurology & Psychiatry
St Louis, Missouri, 63104, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Neurological Institute
New York, New York, 10032, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Neurosciences Institute, Neurology - Charlotte
Charlotte, North Carolina, 28207, United States
Duke Neurological Disorders Clinic
Durham, North Carolina, 27705, United States
Department of Neurology, Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Providence Brain and Spine Inst. ALS Center
Portland, Oregon, 97213, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Temple University School of Medicine
Philadelphia, Pennsylvania, 19140, United States
Vanderbilt University Medical Center - Clinical Research Center
Nashville, Tennessee, 37232, United States
Texas Neurology, PA
Dallas, Texas, 75214, United States
UTHSCSA - First Outpatient Research Unit
San Antonio, Texas, 78229, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
West Virginia University Hospitals
Morgantown, West Virginia, 26506, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226, United States
UZ Leuven
Leuven, Vlaams Brabant, 3000, Belgium
University of Calgary
Calgary, Alberta, T2N 1N4, Canada
University of Alberta
Edmonton, Alberta, T6G 1Z1, Canada
Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, E3B 0C7, Canada
QE II Health Sciences, Nova Scotia Health Authority
Halifax, Nova Scotia, B3H 3A7, Canada
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5, Canada
Hopital Notre-Dame/CHUM
Montreal, Quebec, H2L 4M1, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4, Canada
CHU de Quebec - Univerite' Laval
Québec, Quebec, G1J 1Z4, Canada
Hopital Dupuytren, service de neurologie
Limoges, 87042, France
Hopital Gui de chauliac
Montpellier, 34295, France
CHU de Nice - Hopital Pasteur 2
Nice, 06001, France
Hopital Bretonneau
Tours, 37044, France
University of Ulm, Department of Neurology
Ulm, Baden-Wurttemberg, 89081, Germany
Hannover Medical School, Department of Neurology
Hanover, Lower Saxony, 30625, Germany
Charite Campus Virchow-Klinikum, Department of Neurology
Berlin, 13353, Germany
Clinical Research Centre Beaumont Hospital
Dublin, Dublin 9, Ireland
IRCCS Istituto Auxologico Italiano - U.O. Neurologia
Milan, Lombardy, 20149, Italy
Centro Clinico NEMO - Fondazione Serena Onlus, ASST Grande Ospedale Metropolitano Niguarda, Ospedale Niguarda
Milan, Lombardy, 20162, Italy
Dipartimento di Neuroscienze "Rita Levi Moltalcini" A.O.U. Citta della Salute e della Scienza di Torino P.O. "Molinette"
Turin, Piedmont, 10126, Italy
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Hospital Santa Maria - Centro Hospitalar Lisboa Norte
Lisbon, 1649-035, Portugal
Hospital San Rafael
Madrid, 28016, Spain
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- MD Cytokinetics
- Organization
- Cytokinetics, Inc.
Study Officials
- STUDY DIRECTOR
MD, Cytokinetics
Cytokinetics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2016
First Posted
October 18, 2016
Study Start
October 17, 2016
Primary Completion
October 26, 2018
Study Completion
October 26, 2018
Last Updated
June 15, 2021
Results First Posted
May 12, 2021
Record last verified: 2021-05