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A Study of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

 
Study Focus:
The primary objective of this study is to demonstrate a pharmacodynamic effect of CK 2017357 on measures of skeletal muscle function or fatigability in patients with ALS.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS
Study Category:
Drug Trial
Study Status:
Closed
Phase:
Phase II
Type:
Interventional Trial
with active agents/drugs & a placebo
Funding Source:
Cytokinetics
Study Chair(s)/Principal Investigator(s):
Jeremy M Shefner, MD, PhD (State University of New York - Upstate Medical University)
Clinicaltrials.gov ID:
NCT01089010
NEALS Affiliated?
Yes
Study Summary:
This study is a Phase II, double-blind, randomized, placebo-controlled, three-way crossover study of CK-2017357 in patients with ALS. 36 to 72 patients will be randomized to one of six different treatment sequences. Each treatment sequence consists of three dosing periods; in each dosing period¸ patients receive a single oral dose of placebo, 250 mg of CK-2017357, or 500 mg of CK-2017357. All six treatment sequences will enroll approximately the same number of patients. A washout period of at least 6 days (to a maximum of 10 days) will be employed between the doses for each patient. This study is designed to assess the effect of CK-2017357 on maximal voluntary muscle strength, on the development of fatigue at maximal and sub-maximal voluntary muscle contraction, and on selected pulmonary function parameters. The plasma concentration of CK-2017357 will be measured at selected time points after each of two single doses of CK-2017357 in men and women. The plasma concentration versus time data obtained in this study may be used to develop a population PK model and estimate inter-subject variability of PK parameters in this target patient population, in particular between male and female study patients.

# of Subjects:
72
Enrollment Start Date:
03/01/2010
Enrollment End Date:
12/01/-0001
Posting Last Modified Date:
11/01/2011
Date Study Added to alsconsortium.org:
11/04/2011
Eligibility Criteria
Gender:
Male & Female
Minimum Age:
18
Min Vital Capacity (% predicted normal):
40%
Time since Symptom Onset:
Not applicable
Time since Diagnosis:
Not applicable
Coordinating Center
Contact Information
State University of New York - Upstate Medical University
Syracuse, New York 13210
UNITED STATES
Other Eligibility Criteria:
Inclusion Criteria:

•Able to comprehend and willing to sign an Informed Consent Form (ICF)
•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) (Brooks, et al., 2000)
•Males or Females 18 years of age or older
•Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive
•Maximum voluntary grip strength between 10 & 40 pounds (females) and 10 & 60 pounds (males)
•Able to maintain grip contraction for 15 seconds
•Upright Slow Vital Capacity (SVC) ≥40% of predicted for age, height, and sex
•Able to perform pulmonary function tests
•Pre-study clinical laboratory findings (including troponin I (TnI) and CPK) within normal range, or if outside of the normal range, deemed not clinically significant by the Investigator
•For female patients only: The patient is post-menopausal (≥ 1 year) or sterilized, or if she is of childbearing potential, she is not breastfeeding, her pregnancy test is negative, she has no intention to become pregnant during the course of the study, and she is using contraceptive drugs or devices. For male patients only: Male patients 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 for 10 weeks after the end of the study.

Exclusion Criteria:

•Significant hepatic/renal insufficiency as defined by Upper Limit of Normal (ULN) laboratory findings
•Life expectancy <3 months
•Participation in any trial in which receipt of investigational study drug occurred within 30 days prior to dosing
•Any prior treatment with CK-2017357
•In the opinion of the Investigator, the patient is not suitable to participate in the study

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