A Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT01378676
Last Updated: 2019-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
49 participants
INTERVENTIONAL
2011-06-30
2012-03-31
Brief Summary
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Detailed Description
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In Part B, approximately additional 24 patients will be randomized to one of four different treatment groups as in Part A. Patients in Part B 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Matching Placebo
Placebo (Part A)
Placebo tablets once daily for 14 days (Part A)
Riluzole 50 MG (Part B)
One 50 mg tablet once daily for 14 days (Part B)
Placebo (Part B)
Placebo tablets once daily for 14 days (Part B)
Active Drug Low Dose (CK-2017357 125 mg)
Placebo (Part A)
Placebo tablets once daily for 14 days (Part A)
CK-2017357 (Part A)
One 125 mg CK-2017357 tablet once daily for 14 days (Part A)
Riluzole 50 MG (Part B)
One 50 mg tablet once daily for 14 days (Part B)
Placebo (Part B)
Placebo tablets once daily for 14 days (Part B)
CK-2017357 (Part B)
One 125 mg tablet once daily for 14 days (Part B)
Active Drug Mid Dose (CK-2017357 250 mg)
Placebo (Part A)
Placebo tablets once daily for 14 days (Part A)
CK-2017357 (Part A)
Two 125 mg CK-2017357 tablets once daily for 14 days (Part A)
Riluzole 50 MG (Part B)
One 50 mg tablet once daily for 14 days (Part B)
Placebo (Part B)
Placebo tablets once daily for 14 days (Part B)
CK-2017357 (Part B)
Two 125 mg tablets once daily for 14 days (Part B)
Active Drug High Dose (CK-2017357 375 mg)
CK-2017357 (Part A)
Three 125 mg CK-2017357 tablets once daily for 14 days (Part A)
Riluzole 50 MG (Part B)
One 50 mg tablet once daily for 14 days (Part B)
CK-2017357 (Part B)
Three 125 mg tablets once daily for 14 days (Part B)
Interventions
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Placebo (Part A)
Placebo tablets once daily for 14 days (Part A)
CK-2017357 (Part A)
One 125 mg CK-2017357 tablet once daily for 14 days (Part A)
CK-2017357 (Part A)
Two 125 mg CK-2017357 tablets once daily for 14 days (Part A)
CK-2017357 (Part A)
Three 125 mg CK-2017357 tablets once daily for 14 days (Part A)
Riluzole 50 MG (Part B)
One 50 mg tablet once daily for 14 days (Part B)
Placebo (Part B)
Placebo tablets once daily for 14 days (Part B)
CK-2017357 (Part B)
One 125 mg tablet once daily for 14 days (Part B)
CK-2017357 (Part B)
Two 125 mg tablets once daily for 14 days (Part B)
CK-2017357 (Part B)
Three 125 mg tablets once daily for 14 days (Part B)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Males or females 18 years of age or older
3. 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)
4. Maximum voluntary grip strength in at least one hand between 10 \& 40 pounds (females) and 10 \& 60 pounds (males)
5. Upright Slow Vital Capacity (SVC) \>50% of predicted for age, height, and sex
6. Able to swallow tablets with water
7. Willing and able to remain off riluzole for 4 weeks (Part A only)
8. Currently taking and tolerating a stable dose of 50 mg BID riluzole (Part B only)
9. Willing and able to reduce daily dose of riluzole to 50 mg for 4 weeks (Part B only)
10. Willing and able to refrain from caffeine-containing products during study participation
11. Willing and able to remain off warfarin and theophylline-containing medications during study participation
12. Has a caregiver who is capable of observing and reporting patient status, and also assisting in the proper use of nocturnal oximetry equipment
13. Able to perform pulmonary function tests
Exclusion Criteria
2. 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
3. Any prior treatment with CK-2017357
4. Use of non-invasive positive pressure ventilation (NIPPV) for any part of the day or night
18 Years
ALL
No
Sponsors
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Cytokinetics
INDUSTRY
Responsible Party
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Principal Investigators
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Jeremy Shefner, MD, PhD
Role: STUDY_CHAIR
State University of New York - Upstate Medical University
Locations
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California Pacific Medical Center
San Francisco, California, United States
Mayo Florida
Jacksonville, Florida, United States
University of Kansas
Kansas City, Kansas, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Columbia University Medical Center
New York, New York, United States
SUNY Upstate Medical Center
Syracuse, New York, United States
Carolinas Neuromuscular ALS-MND Center
Charlotte, North Carolina, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Countries
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References
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Shefner JM, Watson ML, Meng L, Wolff AA; Neals/Cytokinetics STUDY Team. A study to evaluate safety and tolerability of repeated doses of tirasemtiv in patients with amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2013 Dec;14(7-8):574-81. doi: 10.3109/21678421.2013.822517. Epub 2013 Aug 19.
Other Identifiers
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CY 4024
Identifier Type: -
Identifier Source: org_study_id
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