A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS) (FORTITUDE-ALS)

A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS) (FORTITUDE-ALS)

Quick Info:

Status:
Currently Recruiting
Estimated Enrollment:
445
Phase:
2
Treatment Type:
Drug: CK-2127107
Trial Type:
Randomized. Parallel Assignment
Sponsor:
Cytokinetics
Primary Investigator:
Contact Information:

Enrollment Criteria:

Forced Ventilation

Breathing Ability

Percent lung function (FVC) or (SVC)
SVC ≥ 65%
Months/Onset

Months Since Onset

Number of months since first
symptoms of ALS
≤ 24 months from diagnosis (not onset)
BiPap Allowed

Non-Invasive Ventilation (NIV)

Can PALS use a BiPAP in the trial?
No
DPS Allowed

Diaphragm Pacer (DPS)

Can PALS use a DPS in the trial?
No
Edaravone Usage

Edaravone Usage

Can a PALS use edaravone (Radicut/Radicava)
while enrolled in the trial?
Yes

Update Notes:

4/2/2018Location updated
4/2/2018Trial name updated
3/23/2018Location updated
3/15/2018Location updated
3/6/2018Location updated
3/1/2018No significant updates
2/20/2018Location updated
2/9/2018No significant updates
2/6/2018Location updated
1/31/2018Location updated
1/24/2018Location updated
1/10/2018Locations updated
1/3/2018Locations updated
12/20/2017Locations updated
12/4/2017Locations updated
11/27/2017Locations updated
11/7/2017Locations updated
10/27/2017Location updated
10/23/2017
10/5/2017Location updated
9/28/2017Location updated
9/15/2017Location updated
9/6/2017No significant updates
8/1/2017Recruitment status and location updated
5/22/2017New trial added

Locations:

CHUM Research Center, Montréal, H2X 0A9
Carol & Frank Morsani Center Advanced Healthcare University of South Florida, Tampa, 33612
Cedars-Sinai Medical Center, Los Angeles, 90048
Cleveland Clinic, Cleveland, 44195
Duchossois Center for Advanced Medicine, Chicago, 60637
Duke Neurological Disorders Clinic, Durham, 27705
Edmonton Kaye Clinic, Edmonton, T6GT 1Z1
Emory Clinic, Atlanta, 30322
Forbes Norris MDA/ALS Research Center, San Francisco, 94115
Froedtert Memorial Lutheran Hospital, Milwaukee, 53226
Hennepin County Medical Center, Minneapolis, 55415
Henry Ford Health System, Detroit, 48202
Hospital For Special Surgery, New York, 10021
Hospital for Special Care, New Britain, 06053
Houston Methodist Hospital, Houston, 77030
Hôpital de l'Enfant-Jésus, CHU de Québec 1401, 18e Rue, Quebec City, G1J 1Z4
IU Health Neuroscience Center of Excellence, Indianapolis, 46202
Mayo Clinic, Jacksonville, 32224
Mayo Clinic, Rochester, 55905
McMaster University Medical Centre, Hamilton, L8N 3Z5
Michigan Medicine, Ann Arbor, 48109
Montreal Neurological Institute and Hospital, Montreal, H3A 2B4
Neurology Associates, P.C., Lincoln, 68506
Penn State Milton S. Hershey Medical Center, Hershey, 17033
Providence Brain and Spine Institute ALS Center, Portland, 97213
SUNY Upstate Medical University, Syracuse, 13210
Saint Louis University, Department of Neurology, Saint Louis, 63104
St. Joseph's Hosp & Med Center - Barrow Neuro. Cen, Phoenix, 85013
Stanford Hospital and Clinics, Stanford, 94305
Texas Neurology, Dallas, 75214
The Ohio State University Wexner Medical Center, Columbus, 43210
UC Irvine, Orange, 92868
UTHSCSA Medical Arts and Research Center, San Antonio, 78229
University of Calgary, Heritage Medical Research C, Calgary, T2N 4Z6
University of Colorado Hospital Anschutz Outpatien, Aurora, 80045
University of Kansas Medical Center, Kansas City, 66160
University of Vermont Medical Center, Burlington, 05405
University of Virginia Health System, Charlottesville, 22908
University of Washington Medical Center, Seattle
VCU Health - Ambulatory Care Center (ACC), Richmond, 23298
Vanderbilt University Medical Center Clinical Research Center, Nashville, 37232
Wake Forest School of Medicine, Winston-Salem, 27157
Washington University School of Medicine, Saint Louis, 63110
West Virginia University, Dept. of Neurology, Morgantown, 26506
George Washington University Medical Faculty Assoc, Washington DC, 20037
University of Iowa Hospitals and Clinics, Iowa City, 52242
Temple University School of Medicine, Philadelphia, 19140
London Health Sciences Centre University Hospital, London, N6A 5A5
University of Florida, Gainesville, 32610

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.
Collaborator(s):
News Articles and Summaries:
ALS Forum:
First Published on Clinicaltrials.gov: 5/12/2017
ClinicalTrials.gov ID: NCT03160898
Trial Protocol as Published on Clinicaltrials.gov:
ClinicalTrials.gov