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Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis

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ClinicalTrials.gov Identifier: NCT02988297
Recruitment Status : Not yet recruiting
First Posted : December 9, 2016
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Revalesio Corporation

Tracking Information
First Submitted Date  ICMJE December 7, 2016
First Posted Date  ICMJE December 9, 2016
Last Update Posted Date January 9, 2019
Estimated Study Start Date  ICMJE July 2019
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
ALS functional rating scale-revised (ALSFRS-R) score [ Time Frame: 24 weeks ]
The mean change of the ALSFRS-R total score
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
The mean change of ALSFRS-R total score [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT02988297 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • Deaths or tracheostomies [ Time Frame: 28 weeks ]
    The cumulative proportion of deaths or tracheostomies
  • Proportion of regulatory T cells (Treg) [ Time Frame: 24 weeks ]
    The mean change in the proportion of Tregs
  • Slow vital capacity (SVC) [ Time Frame: 24 weeks ]
    The mean change of the SVC score
  • ALS assessment questionnaire (ALSAQ-40) score [ Time Frame: 24 weeks ]
    The mean change of the ALS assessment questionnaire (ALSAQ-40) score
  • Adverse events (AEs) [ Time Frame: 28 weeks ]
    The mean number of AEs
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
  • The cumulative proportion of deaths or tracheostomies [ Time Frame: 28 weeks ]
  • The mean change in the proportion of T-reg [ Time Frame: 24 weeks ]
  • The mean change of SVC score [ Time Frame: 24 weeks ]
  • The mean change of ALSAQ-40 score [ Time Frame: 24 weeks ]
  • The mean number of AEs [ Time Frame: 28 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis
Official Title  ICMJE Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis
Brief Summary The purpose of this study is to determine whether nebulized RNS60 is effective in the treatment of amyotrophic lateral sclerosis (ALS).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE
  • Drug: RNS60
    Nebulized RNS60 will be administered by daily inhalation for 24 weeks.
  • Drug: Placebo
    Nebulized Placebo will be administered by daily inhalation for 24 weeks.
Study Arms  ICMJE
  • Experimental: RNS60
    Nebulized RNS60 will be administered by daily inhalation for 24 weeks.
    Intervention: Drug: RNS60
  • Placebo Comparator: Placebo
    Nebulized Placebo will be administered by daily inhalation for 24 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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2016)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02988297
Other Study ID Numbers  ICMJE 06.2.1.H6
Has Data Monitoring Committee Not Provided
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 Not Provided
Responsible Party Revalesio Corporation
Study Sponsor  ICMJE Revalesio Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Revalesio Corporation
Verification Date January 2019

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