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A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

 
Study Focus:
The study will generate data on safety and tolerability after multiple daily doses of CK-2017357 in patients with ALS. Patients will be randomized into one of four different treatment groups, receiving daily oral doses of either placebo, 125 mg, 250 mg, or 375 mg of CK-2017357 for 14 days.
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 Shefner, MD, PhD (SUNY)
Clinicaltrials.gov ID:
NCT01378676
NEALS Affiliated?
No
Study Summary:
Patients will be randomized to one of four different treatment groups: daily oral doses of placebo, 125 mg, 250 mg, or 375 mg of CK-2017357. Patients will be required to decrease their riluzole dose to 50 mg once a day (QD) for 7 days prior to randomization. After this 7 day period, patients will take riluzole at 50 mg QD concurrently with their morning dose of blinded study drug for 14 days.
Participant Duration:
21 days
# of Subjects:
50
Enrollment Start Date:
06/01/2011
Enrollment End Date:
12/01/-0001
Posting Last Modified Date:
03/01/2012
Date Study Added to alsconsortium.org:
11/01/2011
Eligibility Criteria
Gender:
Male & Female
Minimum Age:
18
Min Vital Capacity (% predicted normal):
50%
Time since Symptom Onset:
Not applicable
Time since Diagnosis:
Not applicable
Can participants use Riluzole?
Riluzole use required by protocol
Coordinating Center
Contact Information
Jean Masonek
jmasonek@cytokinetics.com
Cytokinetics
280 East Grand Avenue
California 94080
UNITED STATES
Other Eligibility Criteria:
Key Inclusion Criteria:

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)
Upright Slow Vital Capacity (SVC) >50% of predicted for age, height, and sex
Able to swallow tablets with water
Willing and able to refrain from caffeine-containing products during study participation
Willing and able to remain off warfarin and theophylline-containing medications during study participation
Has a caregiver who is capable of observing and reporting patient status, and also assisting in the proper use of nocturnal oximetry equipment
Able to perform pulmonary function tests

Key Exclusion Criteria:

Life expectancy <3 months
Participation in any trial in which receipt of investigational study drug occurred within 30 days or 5 half-lives of the prior agent, whichever is greater, prior to dosing
Any prior treatment with CK-2017357
Use of non-invasive positive pressure ventilation (NIPPV) for any part of the day or night
Other protocol-defined inclusion/exclusion criteria may apply.

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