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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02936635
Recruitment Status : Completed
First Posted : October 18, 2016
Last Update Posted : February 18, 2019
Sponsor:
Information provided by (Responsible Party):
Cytokinetics

Brief Summary:
The purpose of this study is to assess the long-term safety and tolerability of tirasemtiv in patients with ALS.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis (ALS) Drug: tirasemtiv Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Extension Study of Tirasemtiv for Patients With Amyotrophic Lateral Sclerosis (ALS) Who Completed VITALITY-ALS (CY 4031)
Actual Study Start Date : October 17, 2016
Actual Primary Completion Date : October 26, 2018
Actual Study Completion Date : October 26, 2018


Arm Intervention/treatment
Experimental: tirasemtiv
tirasemtiv 250-500 mg/day
Drug: tirasemtiv
Oral
Other Name: CK-2017357




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) in patient population [ Time Frame: Until end of study, up to 36 months ]

Secondary Outcome Measures :
  1. Time to first use of assisted ventilation or death [ Time Frame: From date of entry into the study until the date of first documented progression or date of death from any cause, which came first, assessed up to 36 months ]
  2. Time to the first occurrence of respiratory insufficiency (defined as tracheostomy or the use of non-invasive ventilation (NIV) for ≥22 hours per day for ≥10 consecutive days) or death [ Time Frame: From date of entry into the study until the date of first documented progression or date of death from any cause, which came first, assessed up to 36 months ]
  3. Time to death [ Time Frame: From date of entry into the study until the date of first documented progression or date of death from any cause, which came first, assessed up to 36 months ]
  4. Decline in percent predicted Slow Vital Capacity (SVC) from baseline [ Time Frame: From date of entry into the study until the date of first documented progression or date of death from any cause, which came first, assessed up to 36 months ]
  5. Decline in ALS Functional Rating Scale - Revised (ALSFRS-R) score from baseline [ Time Frame: From date of entry into the study until the date of first documented progression or date of death from any cause, which came first, assessed up to 36 months ]
  6. Slope of the change from baseline in percent predicted SVC [ Time Frame: First 24 weeks and first 48 weeks of either CY 4031 or CY 4033 ]
  7. Slope of the change from baseline in ALSFRS-R [ Time Frame: First 24 weeks and first 48 weeks of either CY 4031 or CY 4033 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02936635


  Hide Study Locations
Locations
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United States, Arizona
St. Joseph's Hospital and Medical Center - Barrow Neurology Clinics
Phoenix, Arizona, United States, 85013
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
University of California, Irvine
Orange, California, United States, 92868
UC Davis Medical Center
Sacramento, California, United States, 95817
Forbes Norris MDA/ALS Research Center
San Francisco, California, United States, 94115
Stanford Hospital and Clinics
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Hospital for Special Care
New Britain, Connecticut, United States, 06053
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
University of Miami, Miller School of Medicine
Miami, Florida, United States, 33136
Carol & Frank Morsani Center for Advanced Health Care - University of South Florida
Tampa, Florida, United States, 33512
United States, Georgia
The Emory Clinic
Atlanta, Georgia, United States, 30322
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
University of Massachusetts Memorial Medical Center/University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
St. Louis University, Department of Neurology & Psychiatry
Saint Louis, Missouri, United States, 63104
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Neurological Institute
New York, New York, United States, 10032
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Neurosciences Institute, Neurology - Charlotte
Charlotte, North Carolina, United States, 28207
Duke Neurological Disorders Clinic
Durham, North Carolina, United States, 27705
Department of Neurology, Wake Forest School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Providence Brain and Spine Inst. ALS Center
Portland, Oregon, United States, 97213
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140
United States, Tennessee
Vanderbilt University Medical Center - Clinical Research Center
Nashville, Tennessee, United States, 37232
United States, Texas
Texas Neurology, PA
Dallas, Texas, United States, 75214
UTHSCSA - First Outpatient Research Unit
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, West Virginia
West Virginia University Hospitals
Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
University of Alberta
Edmonton, Alberta, Canada, T6G 1Z1
Canada, New Brunswick
Stan Cassidy Centre for Rehabilitation
Fredericton, New Brunswick, Canada, E3B 0C7
Canada, Nova Scotia
QE II Health Sciences, Nova Scotia Health Authority
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Hopital Notre-Dame/CHUM
Montreal, Quebec, Canada, H2L 4M1
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada, H3A 2B4
Canada
CHU de Quebec - Univerite' Laval
Quebec, Canada, G1J 1Z4
France
Hopital Dupuytren, service de neurologie
Limoges Cedex, France, 87042
Hopital Gui de chauliac
Montpellier Cedex 5, France, 34295
CHU de Nice - Hopital Pasteur 2
Nice Cedex 1, France, 06001
Hopital Bretonneau
Tours cedex 9, France, 37044
Germany
University of Ulm, Department of Neurology
Ulm, Baden-Wuerttemberg, Germany, 89081
Hannover Medical School, Department of Neurology
Hannover, Lower Saxony, Germany, 30625
Charite Campus Virchow-Klinikum, Department of Neurology
Berlin, Germany, 13353
Ireland
Clinical Research Centre Beaumont Hospital
Dublin, Ireland, Dublin 9
Italy
IRCCS Istituto Auxologico Italiano - U.O. Neurologia
Milan, Lombardy, Italy, 20149
Centro Clinico NEMO - Fondazione Serena Onlus, ASST Grande Ospedale Metropolitano Niguarda, Ospedale Niguarda
Milan, Lombardy, Italy, 20162
Dipartimento di Neuroscienze "Rita Levi Moltalcini" A.O.U. Citta della Salute e della Scienza di Torino P.O. "Molinette"
Torino, Piemonte, Italy, 10126
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Portugal
Hospital Santa Maria - Centro Hospitalar Lisboa Norte
Lisboa, Portugal, 1649-035
Spain
Hospital San Rafael
Madrid, Spain, 28016
United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Cytokinetics
Investigators
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Study Director: Study Director MD Cytokinetics Cytokinetics

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Responsible Party: Cytokinetics
ClinicalTrials.gov Identifier: NCT02936635     History of Changes
Other Study ID Numbers: CY 4033
2016-002629-13 ( EudraCT Number )
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: December 2018

Keywords provided by Cytokinetics:
Amyotrophic Lateral Sclerosis
ALS
tirasemtiv

Additional relevant MeSH terms:
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Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases