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Trial record 31 of 514 for:    ALS (Amyotrophic Lateral Sclerosis)

A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS) (FORTITUDE-ALS)

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ClinicalTrials.gov Identifier: NCT03160898
Recruitment Status : Completed
First Posted : May 19, 2017
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Cytokinetics

Tracking Information
First Submitted Date  ICMJE May 12, 2017
First Posted Date  ICMJE May 19, 2017
Last Update Posted Date April 5, 2019
Actual Study Start Date  ICMJE July 24, 2017
Actual Primary Completion Date March 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2017)
Change from baseline to Week 12 in the percent predicted slow vital capacity (SVC) [ Time Frame: Baseline to Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03160898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2018)
  • Slope of change from baseline in the mega-score of muscle strength measured by hand held dynamometry and handgrip dynamometry from baseline to Week 12 [ Time Frame: Baseline to Week 12 ]
  • Change from baseline to Week 12 in the ALS Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: Baseline to Week 12 ]
  • Mean plasma concentrations over time of CK-2127107 at Week 12 [ Time Frame: Day 1 to Week 12 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2017)
  • Slope of change from baseline in the mega-score of muscle strength measured by hand held dynamometry and handgrip dynamometry from baseline to Week 12 in patients on CK-2127107 compared to placebo [ Time Frame: Baseline to Week 12 ]
  • Change from baseline to Week 12 in the ALS Functional Rating Scale - Revised (ALSFRS-R) [ Time Frame: Baseline to Week 12 ]
  • Mean plasma concentrations over time of CK-2127107 at Week 12 [ Time Frame: Day 1 to Week 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Official Title  ICMJE A Phase 2, Multi-Center, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)
Brief Summary The purpose of this study is to assess the effect of CK-2127107 versus placebo on respiratory function and other measures of skeletal muscle function in patients with ALS.
Detailed Description Enrolled participants will be dosed with CK-2127107 150, 300, 450 mg or placebo twice daily (300, 600, 900 mg/day or placebo) for a period of 12 weeks.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • Drug: CK-2127107
    Oral
    Other Name: reldesemtiv
  • Drug: Placebo
    Oral
Study Arms  ICMJE
  • Experimental: CK-2127107 300 mg
    Participants will receive CK-2127107 300 mg for 12 weeks
    Intervention: Drug: CK-2127107
  • Experimental: CK-2127107 600 mg
    Participants will receive CK-2127107 600 mg for 12 weeks
    Intervention: Drug: CK-2127107
  • Experimental: CK-2127107 900 mg
    Participants will receive CK-2127107 900 mg for 12 weeks
    Intervention: Drug: CK-2127107
  • Placebo Comparator: Placebo
    Participants will receive placebo for 12 weeks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 3, 2019)
458
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2017)
445
Actual Study Completion Date  ICMJE March 7, 2019
Actual Primary Completion Date March 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of familial or sporadic ALS ≤ 24 months prior to screening
  • Upright Slow Vital Capacity (SVC) ≥ 60% of predicted for age, height and sex at screening
  • Able to swallow tablets
  • A caregiver (if one is needed)
  • Able to perform reproducible pulmonary function tests
  • Pre-study clinical laboratory findings within the normal range or, if outside the normal range, deemed not clinically significant by the Investigator
  • Male patients who have not had a vasectomy and confirmed zero sperm count must agree after receiving the first dose of study drug until 10 weeks after the last dose to either use acceptable methods of contraception or abstain from sex
  • Female patients must be post-menopausal or sterilized or must not be breastfeeding, have a negative pregnancy test, have no intention to become pregnant during the study and use acceptable methods of contraception or abstain from heterosexual intercourse from Screening until 10 weeks after last dose of study drug
  • Patients must be either on riluzole for at least 30 days prior to screening or have not taken riluzole for at least 30 days prior to screening and not planning to start riluzole during the course of the study.

Exclusion Criteria:

  • At the time of screening, any use of non-invasive ventilation (NIV), e.g. continuous positive airway pressure [CPAP], noninvasive bi-level positive airway pressure [NPPV] or noninvasive volume ventilation [NVV]for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation
  • Neurological impairment due to a condition other than ALS
  • Presence at screening of any medically significant cardiac, pulmonary, GI, musculoskeletal, or psychiatric illness that might interfere with the patient's ability to comply with study procedures or that might confound the interpretation of clinical safety or efficacy data
  • Has taken any investigational study drug within 30 days or five half-lives of the prior agent, whichever is longer, prior to dosing
  • Known to have received CK-2127107 or tirasemtiv in any previous clinical trial
  • Has received or is considering receiving during the course of the study any form of stem cell therapy for the treatment of ALS
  • Has received or is considering receiving during the course of the study any form of gene therapy for the treatment of ALS
  • Has received or is considering obtaining during the course of the study a diaphragmatic pacing system
  • History of substance abuse within the past 2 years
  • Use of certain medications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Ireland,   Netherlands,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03160898
Other Study ID Numbers  ICMJE CY 5022
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cytokinetics
Study Sponsor  ICMJE Cytokinetics
Collaborators  ICMJE Astellas Pharma Inc
Investigators  ICMJE
Study Director: Study Director MD Cytokinetics
PRS Account Cytokinetics
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP