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

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

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:

Michigan Medicine, Ann Arbor, 48109
University of Colorado Hospital Anschutz Outpatien, Aurora, 80045
University of Calgary, Heritage Medical Research C, Calgary, T2N 4Z6
Duchossois Center for Advanced Medicine, Chicago, 60637
The Ohio State University Wexner Medical Center, Columbus, 43210
Texas Neurology, Dallas, 75214
Henry Ford Health System, Detroit, 48202
Duke Neurological Disorders Clinic, Durham, 27705
McMaster University Medical Centre, Hamilton, L8N 3Z5
Penn State Milton S. Hershey Medical Center, Hershey, 17033
IU Health Neuroscience Center of Excellence, Indianapolis, 46202
Neurology Associates, P.C., Lincoln, 68506
Froedtert Memorial Lutheran Hospital, Milwaukee, 53226
Hennepin County Medical Center, Minneapolis, 55415
Montreal Neurological Institute and Hospital, Montreal, H3A 2B4
West Virginia University, Dept. of Neurology, Morgantown, 26506
Hospital for Special Care, New Britain, 06053
Hospital For Special Surgery, New York, 10021
UC Irvine, Orange, 92868
St. Joseph's Hosp & Med Center - Barrow Neuro. Cen, Phoenix, 85013
Providence Brain and Spine Institute ALS Center, Portland, 97213
Hôpital de l'Enfant-Jésus, CHU de Québec 1401, 18e Rue, Quebec City, G1J 1Z4
Saint Louis University, Department of Neurology, Saint Louis, 63104
UTHSCSA Medical Arts and Research Center, San Antonio, 78229
Forbes Norris MDA/ALS Research Center, San Francisco, 94115
University of Washington Medical Center, Seattle
Stanford Hospital and Clinics, Stanford, 94305
SUNY Upstate Medical University, Syracuse, 13210
Wake Forest School of Medicine, Winston-Salem, 27157
University of Virginia Health System, Charlottesville, 22908
Cleveland Clinic, Cleveland, 44195
Vanderbilt University Medical Center Clinical Research Center, Nashville, 37232
CHUM Research Center, Montréal, H2X 0A9

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