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Cytokinetics, Incorporated Message Board

  • stan_long@ymail.com stan_long Feb 4, 2013 12:52 PM Flag

    Good Old Fashioned Shake Out.............Read This.........

    Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)...WAS Updated on 01/29/2013...no one was privy to the update until when..hmmm tomorrow afternoon release with the earning or lack of....dont believe...check it out yourself................
    Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)
    NOTICE THE LAST LINE...Processed on 01/31/2013...

    This study is currently recruiting participants.

    Verified December 2012 by Cytokinetics

    Sponsor:

    Cytokinetics

    Information provided by (Responsible Party):

    Cytokinetics

    ClinicalTrials.gov Identifier:

    NCT01709149

    First received: October 16, 2012

    Last updated: January 29, 2013

    Last verified: December 2012

    History of Changes

    Full Text View
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    No Study Results Posted
    Disclaimer
    How to Read a Study Record

    Purpose

    The purpose of this research study is to evaluate the safety and effectiveness of CK-2017357 when taken with or without riluzole (also called Rilutek®) in patients with Amyotrophic Lateral Sclerosis (ALS).

    Condition

    Intervention

    Phase

    Amyotrophic Lateral Sclerosis

    Drug: CK-2017357
    Other: Placebo tablets

    Phase 2

    Study Type:

    Interventional

    Study Design:

    Allocation: Randomized
    Endpoint Classification: Safety/Efficacy Study
    Intervention Model: Parallel Assignment
    Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
    Primary Purpose: Treatment

    Official Title:

    A Phase IIb, Multi-National, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS) (BENEFIT-ALS)

    Resource links provided by NLM:

    Genetics Home Reference related topics: amyotrophic lateral sclerosis

    MedlinePlus related topics: Amyotrophic Lateral Sclerosis
    U.S. FDA Resources

    Further study details as provided by Cytokinetics:

    Primary Outcome Measures: •The change from baseline to the average of the ALS Functional Rating Scale-Revised (ALSFRS-R) total score obtained at Visits 6 and 7 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    Secondary Outcome Measures: •Change in Maximum Voluntary Ventilation (MVV) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    •Change in Sniff Nasal Inspiratory Pressure (SNIP) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    •Change in Slow Vital Capacity (SVC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    •Change in handgrip strength and fatigability [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    As measured by maximum handgrip strength and sub-maximum handgrip strength

    •Change in muscle strength by hand-held dynamometry (HHD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

    As determined by the megascore of:

    Elbow flexion (bilateral), wrist extension (bilateral), knee extension (bilateral), and ankle dorsiflexion (bilateral)

    Estimated Enrollment:

    400

    Study Start Date:

    October 2012

    Estimated Study Completion Date:

    October 2013

    Estimated Primary Completion Date:

    October 2013 (Final data collection date for primary outcome measure)

    Arms

    Assigned Interventions

    Experimental: CK-2017357
    125 mg tablets

    Drug: CK-2017357
    Other Name: tirasemtiv


    Placebo Comparator: Placebo
    Placebo tablets

    Other: Placebo tablets

    Detailed Description:

    The length of the study, including screening, dosing, and follow-up, is approximately 20 weeks. After a one-week open-label phase during which all patients will receive CK-2017357 125 milligrams (mg) twice daily, patients will be randomized one to one (fifty-fifty) to receive double-blind CK-2017357 or matching placebo. The CK-2017357/placebo dose will be increased no faster than weekly to each patient's highest tolerated daily dose, with a maximum of 250 mg twice daily. The dose may be decreased based on tolerability. Patients will continue treatment at the highest tolerated dose to complete a total of 12 weeks of double-blind treatment. Patients may be on riluzole or not on riluzole at study entry. Patients not on riluzole must stay off riluzole. Patients on riluzole who are getting double-blind CK-2017357 will be given riluzole at half the labeled dosage (50 mg once a day instead of 50 mg twice a day). Blood tests for safety will be performed. Information about any side effects that may occur will also be collected.

    Eligibility

    Ages Eligible for Study:

    18 Years and older

    Genders Eligible for Study:

    Both

    Accepts Healthy Volunteers:

    No

    Criteria

    Inclusion Criteria:
    1.Able to comprehend and willing to sign an Informed Consent Form (ICF)
    2.Male or female 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.Upright Slow Vital Capacity (SVC) 60 % of predicted for age, height and sex
    5.At least 4 of the 12 ALSFRS-R questions must be scored 2 or 3
    6.Diminished but measurable maximum voluntary grip strength in at least one hand; i.e., between 10 and 40 pounds (females) and 10 and 60 pounds (males)
    7.Able to swallow tablets without crushing
    8.A caregiver (if one is needed) who can and will observe and report the patient's status
    9.Pre-study clinical laboratory findings within normal range or, if outside of the normal range, deemed not clinically significant by the Investigator
    10.Male patients must 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 during and for 10 weeks after the end of the study
    11.Female patients must be post-menopausal (≥ 1 year) or sterilized, or, if of childbearing potential, not be breastfeeding, have a negative pregnancy test, have no intention to become pregnant during the course of the study, and use contraceptive drugs or devices as detailed in item 10 for the duration of the study and for 10 weeks after the end of the study
    12.Patients must be either on a stable dose of riluzole 50 mg twice daily for at least 30 days prior to screening or have not taken riluzole for at least 30 days prior to screening and are willing not to begin riluzole use during the conduct of this study.

    Exclusion Criteria:
    1.Any use of non-invasive positive pressure ventilation (NIPPV, e.g. continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP]) for any portion of the day, or mechanical ventilation via tracheostomy, or on any form of oxygen supplementation
    2.Patients with a diaphragm pacing system (DPS) at study entry or who anticipate DPS placement during the course of the study
    3.Body Mass Index (BMI) of 19.0 kg/m2 or lower
    4.Unwilling to discontinue theophylline-containing medications during study participation
    5.Serum chloride

 
CYTK
4.40-0.06(-1.35%)Aug 20 4:00 PMEDT

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