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

Completed · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

The purpose of this study was to assess the effect of CK-2127107 (hereafter referred to as reldesemtiv) versus placebo on respiratory function and other measures of skeletal muscle function in patients with ALS.

Key facts

Study ID

NCT03160898

Run by

Cytokinetics

People needed

458

Starts

2017-07-24

Expected to finish

2019-03-07

Last updated by the study team

2020-09-11

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of familial or sporadic ALS ≤ 24 months prior to screening
• Upright Slow Vital Capacity (SVC) ≥ 60% of predicted for age, height and sex at screening
• Able to swallow tablets
• A caregiver (if one is needed)
• Able to perform reproducible pulmonary function tests
• Pre-study clinical laboratory findings within the normal range or, if outside the normal range, deemed not clinically significant by the Investigator
• Male patients who have not had a vasectomy and confirmed zero sperm count must agree after receiving the first dose of study drug until 10 weeks after the last dose to either use acceptable methods of contraception or abstain from sex
• Female patients must be post-menopausal or sterilized or must not be breastfeeding, have a negative pregnancy test, have no intention to become pregnant during the study and use acceptable methods of contraception or abstain from heterosexual intercourse from Screening until 10 weeks after last dose of study drug
• Patients must be either on riluzole for at least 30 days prior to screening or have not taken riluzole for at least 30 days prior to screening and not planning to start riluzole during the course of the study.
• Patients on edaravone must have completed at least 2 cycles of dosing with edaravone at the time of screening or have not taken edaravone for at least 30 days prior to screening and not planning to start edaravone during the course of the study.

You may not qualify if…

• At the time of screening, any use of non-invasive ventilation (NIV), e.g. continuous positive airway pressure [CPAP], noninvasive bi-level positive airway pressure [NPPV] or noninvasive volume ventilation [NVV] for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation
• Neurological impairment due to a condition other than ALS
• Presence at screening of any medically significant cardiac, pulmonary, 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 five half-lives of the prior agent, whichever is longer, prior to dosing
• Known to have received CK-2127107 or tirasemtiv in any previous clinical trial
• Has received or is considering receiving during the course of the study any form of stem cell therapy for the treatment of ALS
• Has received or is considering receiving during the course of the study any form of gene therapy for the treatment of ALS
• Has received or is considering obtaining during the course of the study a diaphragmatic pacing system
• History of substance abuse within the past 2 years
• Use of certain medications

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California Irvine — Orange, California, United States
• Forbes Norris MDA/ALS Research Center — San Francisco, California, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• University of Colorado Hospital Anschutz Outpatient Pavilion — Aurora, Colorado, United States
• Hospital for Special Care — New Britain, Connecticut, United States
• George Washington University Medical Faculty Associates — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Carol & Frank Morsani Center for Advanced Healthcare - University of South Florida — Tampa, Florida, United States
• Emory Clinic — Atlanta, Georgia, United States
• Duchossois Center for Advanced Medicine — Chicago, Illinois, United States
• IU Health Neuroscience Center of Excellence — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins University - Outpatient Center — Baltimore, Maryland, United States
• University of Massachusetts Memorial Medical Center/University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Michigan Medicine — Ann Arbor, Michigan, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Louis University, Department of Neurology — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Neurology Associates, P.C. — Lincoln, Nebraska, United States
• St. Joseph's Hospital and Medical Center - Barrow Neurological Clinics — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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