Pharmacokinetic And Pharmacodynamic
Study With Patients With Amyotrophic Lateral Sclerosis (ALS)
Trial Status
Open for Enrollment
What is the Purpose of this Study?
To demonstrate a pharmacodynamic effect of CK-2017357 on measures of
skeletal muscle function or fatigability in patients with ALS to determine
if this compound could be a potential new therapy for improving muscle
weakness and muscle fatigue in patients with ALS.
Who is Eligible?
Patients 18 years or older who. Have probable or definite criteria for
a diagnosis of ALS and other criteria that will be later explained in
detail by the study coordinator
What is involved in this Study?
Patients will be randomized to one of six different treatment sequences.
Each treatment sequence consists of three dosing periods in which patients
receive single oral doses of placebo, 250 mg, and 500 mg of CK-2017357.
All six treatment sequences will enroll approximately the same number
of patients. A washout-out period of at least 6 days (to a maximum of
10 days) will be employed between the doses for each patient.
How long
is the Study?
The study is approximately 2 months long.
For more information contact: Lynne
E. Flynn, CCRC, study coordinator, at 602-258-2863 or lynneflynn@pnal.net
