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Quick Info
Status
This study has been completed
Estimated Enrollment
458
Phase
2
Treatment Type
Drug: CK-2127107
Trial Type
Randomized. Parallel Assignment
Sponsor
Primary Investigator
Study Director MD Cytokinetics
Contact Information
Locations
Canada, Alberta
University of Calgary, Heritage Medical Research C, Calgary, AB, T2N 4Z6, Canada
Edmonton Kaye Clinic, Edmonton, AB, T6GT 1Z1, Canada
Canada, Ontario
McMaster University Medical Centre, Hamilton, ON, L8N 3Z5, Canada
London Health Sciences Centre University Hospital, London, ON, N6A 5A5, Canada
Canada, Quebec
Montreal Neurological Institute and Hospital, Montreal, QC, H3A 2B4, Canada
CHUM Research Center, Montréal, QC, H2X 0A9, Canada
Hôpital de l'Enfant-Jésus, CHU de Québec 1401, 18e Rue, Quebec City, QC, G1J 1Z4, Canada
Ireland, Other
Beaumont Hospital, Dublin, Ireland
United States, Arizona
St. Joseph's Hosp & Med Center - Barrow Neuro. Cen, Phoenix, AZ, 85013, United States
United States, California
Cedars-Sinai Medical Center, Los Angeles, CA, 90048, United States
UC Irvine, Orange, CA, 92868, United States
Forbes Norris MDA/ALS Research Center, San Francisco, CA, 94115, United States
Stanford Hospital and Clinics, Stanford, CA, 94305, United States
United States, Colorado
University of Colorado Hospital Anschutz Outpatien, Aurora, CO, 80045, United States
United States, Connecticut
Hospital for Special Care, New Britain, CT, 06053, United States
United States, District of Columbia
George Washington University Medical Faculty Assoc, Washington DC, DC, 20037, United States
United States, Florida
University of Florida, Gainesville, FL, 32610, United States
Mayo Clinic, Jacksonville, FL, 32224, United States
Carol & Frank Morsani Center Advanced Healthcare University of South Florida, Tampa, FL, 33612, United States
United States, Georgia
Emory Clinic, Atlanta, GA, 30322, United States
United States, Illinois
Duchossois Center for Advanced Medicine, Chicago, IL, 60637, United States
United States, Indiana
IU Health Neuroscience Center of Excellence, Indianapolis, IN, 46202, United States
United States, Iowa
University of Iowa Hospitals and Clinics, Iowa City, IA, 52242, United States
United States, Kansas
University of Kansas Medical Center, Kansas City, KS, 66160, United States
United States, Michigan
Michigan Medicine, Ann Arbor, MI, 48109, United States
Henry Ford Health System, Detroit, MI, 48202, United States
United States, Minnesota
Hennepin County Medical Center, Minneapolis, MN, 55415, United States
Mayo Clinic, Rochester, MN, 55905, United States
United States, Missouri
Saint Louis University, Department of Neurology, Saint Louis, MO, 63104, United States
Washington University School of Medicine, Saint Louis, MO, 63110, United States
United States, Nebraska
Neurology Associates, P.C., Lincoln, NE, 68506, United States
United States, New York
Hospital For Special Surgery, New York, NY, 10021, United States
SUNY Upstate Medical University, Syracuse, NY, 13210, United States
United States, North Carolina
Duke Neurological Disorders Clinic, Durham, NC, 27705, United States
Wake Forest School of Medicine, Winston-Salem, NC, 27157, United States
United States, Ohio
Cleveland Clinic, Cleveland, OH, 44195, United States
The Ohio State University Wexner Medical Center, Columbus, OH, 43210, United States
United States, Oregon
Providence Brain and Spine Institute ALS Center, Portland, OR, 97213, United States
Oregon Health & Science University, Portland, OR, 97239, United States
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center, Hershey, PA, 17033, United States
Temple University School of Medicine, Philadelphia, PA, 19140, United States
United States, Tennessee
Vanderbilt University Medical Center Clinical Research Center, Nashville, TN, 37232, United States
United States, Texas
Texas Neurology, Dallas, TX, 75214, United States
Houston Methodist Hospital, Houston, TX, 77030, United States
UTHSCSA Medical Arts and Research Center, San Antonio, TX, 78229, United States
United States, Vermont
University of Vermont Medical Center, Burlington, VT, 05405, United States
United States, Virginia
University of Virginia Health System, Charlottesville, VA, 22908, United States
VCU Health - Ambulatory Care Center (ACC), Richmond, VA, 23298, United States
United States, Washington
University of Washington Medical Center, Seattle, WA, United States
United States, West Virginia
West Virginia University, Dept. of Neurology, Morgantown, WV, 26506, United States
United States, Wisconsin
Froedtert Memorial Lutheran Hospital, Milwaukee, WI, 53226, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
SVC ≥ 65%
Months Since Onset
Number of months since first symptoms of ALS.
≤ 24 months from diagnosis (not onset)
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
No
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
No
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Update Notes
No significant updates
2/18/2020
Trial complete
4/8/2019
No significant updates
3/11/2019
Recruitment status updated
2/15/2019
Location updated
10/24/2018
Location updated
9/25/2018
Trial details updated
9/10/2018
Location updated
4/2/2018
Trial name updated
4/2/2018
Location updated
3/23/2018
Location updated
3/15/2018
Location updated
3/6/2018
No significant updates
3/1/2018
Location updated
2/20/2018
No significant updates
2/9/2018
Location updated
2/6/2018
Location updated
1/31/2018
Location updated
1/24/2018
Locations updated
1/10/2018
Locations updated
1/3/2018
Locations updated
12/20/2017
Locations updated
12/4/2017
Locations updated
11/27/2017
Locations updated
11/7/2017
Location updated
10/27/2017
10/23/2017
Location updated
10/5/2017
Location updated
9/28/2017
Location updated
9/15/2017
No significant updates
9/6/2017
Recruitment status and location updated
8/1/2017
New trial added
5/22/2017

Other Information

Purpose
The purpose of this study is to assess the effect of CK-2127107 versus placebo on respiratory function and other measures of skeletal muscle function in patients with ALS.
Eligibility
18-80 years, all genders, not accepting healthy volunteers
Details
May be referred to as the FORTITUDE-ALS clinical trial. Enrolled participants will be dosed with CK-2127107 150, 300, 450 mg or placebo twice daily (300, 600, 900 mg/day or placebo) for a period of 12 weeks.
ALS Forum
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