Clinical Trial Details

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

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Trial Information

Broad Health Condition Amyotrophic Lateral Sclerosis

Specific Health Condition

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,WA,

Hospital
Department of Neurology, Westmead Hospital
Royal Brisbane and Women's Hospital

Phase of TrialPhase 2

Trial 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.
Eligibility

Key inclusion criteria

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

Minimum age18 Years

Maximum age80 Years

GenderAll

Can Healthy volunteers participate?No

Contact details and further information

Sponsor Primary Sponsor Type: Commercial sector/Industry
Primary Sponsor Name: Cytokinetics

Trial websitehttps://clinicaltrials.gov/show/NCT03160898

Trial IDNCT03160898