Study Purpose:
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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
Placebo, 250 mg CK-2017357, 500 mg CK-2017357
Placebo:
Phase:
Phase 2
Study Chair(s)/Principal Investigator(s):
Jeremy M Shefner, MD, PhD, State University of New York - Upstate Medical University
Clinicaltrials.gov ID:
Neals Affiliated?
Yes
Coordinating Center Contact Information
State University of New York - Upstate Medical University
Syracuse, New York, 13210 United States
Full Study Summary:
Study Sponsor:
Cytokinetics
Estimated Enrollment:
67
Estimated Study Start Date:
02 / 28 / 2010
Estimated Study Completion Date:
11 / 01 / 2010
Posting Last Modified Date:
05 / 10 / 2019
Date Study Added to neals.org:
03 / 18 / 2010
Minimum Age:
18 Years
Maximum Age:
N/A
Inclusion CriteriaFor enrollment, patients were required to satisfy all of the following criteria at baseline:
1. Able to comprehend and willing to sign an Informed Consent Form (ICF)
1. 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, Miller et al. 2000)
2. Males or females 18 years of age or older
3. Body Mass Index (BMI) of 18.0 to 30.0 kg/m2, inclusive
4. Maximum voluntary grip strength in at least one hand between 10 and 40 pounds (females) or 10 and 60 pounds (males)
5. Able to swallow capsules with water
6. Upright Slow Vital Capacity (SVC) > 40% of predicted for age, height, and sex [See Appendix 16.6.1]
7. Able to perform pulmonary function tests
8. Pre-study clinical laboratory findings (including troponin I [TnI] and creatine phosphokinase [CPK]) within normal range, or, if outside of the normal range, deemed not clinically significant by the Investigator
9. 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 the duration of the study and for 10 weeks after the end of the study.
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
Patients satisfying any of the following criteria at baseline were excluded from enrollment:
1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN)
2. Life expectancy < 3 months
3. Participation in any trial in which receipt of investigational study drug occurred within 30 days prior to dosing
4. Any prior treatment with CK-2017357
5. In the opinion of the Investigator, the patient is not suitable to participate in the study
Phoenix Neurological Associates, Ltd.
Phoenix, Arizona
85018
United States
University Neurology Associates
Fresno, California
93701
United States
California Pacific Medical Center
San Francisco, California
94115
United States
Mayo Clinic Florida
Jacksonville, Florida
32224
United States
University of Kentucky
Lexington, Kentucky
40536
United States
Johns Hopkins Hospital
Baltimore, Maryland
21287
United States
Massachusetts General Hospital
Boston, Massachusetts
02114
United States
Washington University
Saint Louis, Missouri
63110
United States
SUNY Upstate Medical Center
Syracuse, New York
13210
United States
Duke University
Durham, North Carolina
27705
United States
Providence ALS Center
Portland, Oregon
97213
United States
Drexel University College of Medicine, Dept of Neurology
Philadelphia, Pennsylvania
19102
United States
Penn State
University Park, Pennsylvania
17033
United States
The University of Texas Health Science Center at San Antonio
San Antonio, Texas
78229
United States
University of Vermont
Burlington, Vermont
05401
United States