Dose Titration Study to Test Safety and Effects of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

Completed · Phase 2 · Has a placebo group

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

A Phase II, double-blind, randomized, placebo-controlled ascending dose titration study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of multiple ascending doses of CK-2017357 to an individual patient maximum tolerated dose (MTD), using a within-patient twice daily (BID) dose-titration regimen in ALS patients on 50 mg riluzole once daily (QD).

Key facts

Study ID

NCT01486849

Run by

Cytokinetics

People needed

27

Starts

2011-11-01

Expected to finish

2012-03-01

Last updated by the study team

2019-05-03

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)
• Males or females 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)
• Maximum voluntary grip strength in at least one hand between 10 \& 40 pounds (females) and 10 \& 60 pounds (males)
• Able to swallow tablets with water
• Currently taking and tolerating a stable dose of 50 mg BID riluzole
• Willing and able to reduce daily dose of riluzole to 50mg QD for 5 weeks
• Not currently taking or willing and able to remain off theophylline-containing medications during study participation
• Patient has a caregiver who is capable of observing and reporting patient status
• Upright Slow Vital Capacity (SVC) >50% of predicted for age, height, and sex
• Able to perform pulmonary function tests

You may not qualify if…

• Life expectancy <3 months
• Receipt of investigational study drug within 30 days or 5 half-lives of the prior agent, whichever is greater, prior to dosing
• Any prior treatment with CK-2017357
• Any use of non-invasive positive pressure ventilation (NIPPV), such as Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP)
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• University of California at San Francisco, Fresno Campus, Central California Neurological Institute — Fresno, California, United States
• Coordinated Clinical Research — La Jolla, California, United States
• University of California at Irvine, ALS and Neuromuscular Center — Orange, California, United States
• Hospital for Special Care — New Britain, Connecticut, United States
• Massachusetts General Hospital, Neurology Clinical Trials Unit — Charlestown, Massachusetts, United States
• Washington University — St Louis, Missouri, United States
• Cornell Faculty, Hospital for Special Surgery — New York, New York, United States
• Duke University School of Medicine, Division of Neurology — Durham, North Carolina, United States
• Ohio State University, Department of Neurology — Columbus, Ohio, United States
• Providence ALS Center — Portland, Oregon, United States
• University of Texas Health Science Center, Department of Neurology — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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