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Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis
This study is not yet open for participant recruitment.
Verified April 2017 by Revalesio Corporation
Sponsor:
Revalesio Corporation
Information provided by (Responsible Party):
Revalesio Corporation
ClinicalTrials.gov Identifier:
NCT02988297
First received: December 7, 2016
Last updated: April 10, 2017
Last verified: April 2017
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Purpose
The purpose of this study is to determine whether nebulized RNS60 is effective in the treatment of amyotrophic lateral sclerosis (ALS).
| Condition | Intervention | Phase |
|---|---|---|
| Amyotrophic Lateral Sclerosis | Drug: RNS60 Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis |
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 Revalesio Corporation:
Primary Outcome Measures:
- ALS functional rating scale-revised (ALSFRS-R) score [ Time Frame: 24 weeks ]The mean change of the ALSFRS-R total score
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 140 |
| Anticipated Study Start Date: | January 2019 |
| Estimated Study Completion Date: | January 2022 |
| Estimated Primary Completion Date: | January 2022 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: RNS60
Nebulized RNS60 will be administered by daily inhalation for 24 weeks.
|
Drug: RNS60
Nebulized RNS60 will be administered by daily inhalation for 24 weeks.
|
|
Placebo Comparator: Placebo
Nebulized Placebo will be administered by daily inhalation for 24 weeks.
|
Drug: Placebo
Nebulized Placebo will be administered by daily inhalation for 24 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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More Information
| Responsible Party: | Revalesio Corporation |
| ClinicalTrials.gov Identifier: | NCT02988297 History of Changes |
| Other Study ID Numbers: |
06.2.1.H6 |
| Study First Received: | December 7, 2016 |
| Last Updated: | April 10, 2017 |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Additional relevant MeSH terms:
|
Sclerosis Motor Neuron Disease Amyotrophic Lateral Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases |
Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases |
ClinicalTrials.gov processed this record on June 23, 2017