Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)

Completed · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357 when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic Lateral Sclerosis (ALS).

Key facts

Study ID: NCT01709149
Run by: Cytokinetics
People needed: 711
Starts: 2012-10-01
Expected to finish: 2014-03-01
Last updated by the study team: 2020-03-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Able to comprehend and willing to sign an Informed Consent Form (ICF)
Male or female 18 years of age or older
A diagnosis of familial or sporadic ALS (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria)
Upright Slow Vital Capacity (SVC) >50 % of predicted for age, height and sex
At least 4 of the 12 ALSFRS-R questions must be scored 2 or 3
Diminished but measurable maximum voluntary grip strength in at least one hand; i.e., between 10 and 50 pounds (females) and 10 and 70 pounds (males)
Able to swallow tablets without crushing
A caregiver (if one is needed) who can and will observe and report the patient's status
Pre-study clinical laboratory findings within normal range or, if outside of the normal range, deemed not clinically significant by the Investigator
Male patients must agree for the duration of the study and 10 weeks after the end of the study to use a condom during sexual intercourse with female partners who are of reproductive potential and to have female partners use an additional effective means of contraception (e.g., diaphragm plus spermicide, or oral contraceptives) or the male patient must agree to abstain from sexual intercourse during and for 10 weeks after the end of the study
Female patients must be post-menopausal (≥ 1 year) or sterilized, or, if of childbearing potential, not be breastfeeding, have a negative pregnancy test, have no intention to become pregnant during the course of the study, and use contraceptive drugs or devices as detailed in item 10 for the duration of the study and for 10 weeks after the end of the study
Patients must be either on a stable dose of riluzole 50 mg twice daily for at least 30 days prior to screening or have not taken riluzole for at least 30 days prior to screening and are willing not to begin riluzole use during the conduct of this study.

You may not qualify if…

Any use of non-invasive positive pressure ventilation (NIPPV, e.g. continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]) for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation
Patients with a diaphragm pacing system (DPS) at study entry or who anticipate DPS placement during the course of the study
Body Mass Index (BMI) of 19.0 kg/m2 or lower
Unwilling to discontinue tizanidine and theophylline-containing medications during study participation
Serum chloride < 100 mmol/L
Neurological impairment due to a condition other than ALS, including history of transient ischemic attack (TIA) within the past year
Presence at screening of any medically significant cardiac, pulmonary, gastrointestinal (GI), musculoskeletal, or psychiatric illness that might interfere with the patient's ability to comply with study procedures or that might confound the interpretation of clinical safety or efficacy data
Has taken any investigational study drug within 30 days or 5 half-lives of the prior agent, whichever is greater, prior to dosing
Previously received CK-2017357 in any previous clinical trial

Where it is running

University of California, San Diego — La Jolla, California, United States
UC Irvine ALS & Neuromuscular Center — Orange, California, United States
Coordinated Clinical Research — San Diego, California, United States
California Pacific Medical Center Forbes Norris MDA/ALS Research Center — San Francisco, California, United States
Hospital for Special Care — New Britain, Connecticut, United States
The George Washington University — Washington D.C., District of Columbia, United States
Mayo Clinic Florida Department of Neurology — Jacksonville, Florida, United States
Emory University, School of Medicine — Atlanta, Georgia, United States
Georgia Health Sciences University — Augusta, Georgia, United States
Indiana University Department of Neurology — Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
University of Kansas — Kansas City, Kansas, United States
Johns Hopkins University — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
University of Massachusetts Medical School — Worcester, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Henry Ford Hospital — Detroit, Michigan, United States
St Mary's Healthcare — Grand Rapids, Michigan, United States
Hennepin County Medical Center - Berman Center for Research — Minneapolis, Minnesota, United States
Saint Louis University — St Louis, Missouri, United States
Washington University — St Louis, Missouri, United States
Neurology Associates — Lincoln, Nebraska, United States
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
Hospital for Special Surgery — New York, New York, United States
Barrow Neurology — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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