Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis

Study Purpose:

The purpose of this study is to determine whether nebulized RNS60 is effective in the treatment of amyotrophic lateral sclerosis (ALS).

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Active, not yet recruiting

Phase:

Phase II

Study Chair(s)/Principal Investigator(s):

Clinicaltrials.gov ID (11 digit #):

NCT02988297

Neals Affiliated?

No

Coordinating Center Contact Information


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Full Study Summary:

Study Sponsor:

Revalesio Corporation

Participant Duration:

Estimated Enrollment:

140

Estimated Study Start Date:

01/01/2018

Estimated Study Completion Date:

01/01/2021

Posting Last Modified Date:

12/16/2016

Date Study Added to alsconsortium.org:

12/16/2016
  • More Information

    Primary Outcome Measures:

    The mean change of the ALS functional rating scale-revised (ALSFRS-R) total score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

    Secondary Outcome Measures:

    The cumulative proportion of deaths or tracheostomies [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    The mean change in the proportion of regulatory T cells (Treg) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The mean change of the slow vital capacity (SVC) score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The mean change of the ALS assessment questionnaire (ALSAQ-40) score [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The mean number of adverse events (AEs) [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    80

    Time since Symptom Onset:

    Time since Diagnosis:

    <36 months

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    Probable, probable-laboratory supported, or definite ALS, either sporadic or familial according to modified El Escorial criteria
    Disease duration < 3 years
    Age 18 to 80
    Able to provide informed consent and to comply with study procedures
    Subjects must not have taken riluzole for at least 30 days, or be on a stable dose of riluzole for at least 30 days, prior to screening (riluzole-naïve participants are permitted in the study)
    Women must not be lactating or able to become pregnant (e.g. post menopausal, surgically sterile, or using adequate birth control) for the duration of the study, and for 3 months after study completion
    Men should practice contraception for the duration of the study and for 3 months after completion

    Exclusion Criteria:

    Diagnosis of a motor neuron disease other than ALS (e.g., primary lateral sclerosis, progressive muscular atrophy, progressive bulbar palsy)
    Clinically significant unstable medical condition (other than ALS) that would pose a risk to the participant if they were to participate in the study or that would impact survival or functional disability in the next 12 months
    Abnormal liver function defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times the upper limit of the normal
    Renal insufficiency (Glomerular Filtration Rate < 60)
    Active pulmonary disease
    Prior poor compliance with an inhalation device
    The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the participant to provide informed consent, according to judgment by the principal investigator.
    History of human immunodeficiency virus (HIV) infection, clinically significant chronic hepatitis, or other active infection.
    Active participation in another ALS clinical trial within 30 days of the Screening Visit
    Other experimental treatments or anti-inflammatory/immunomodulatory medications used in the preceding 3 months

  • Site Contact Information