Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02988297 |
Recruitment Status :
Not yet recruiting
First Posted : December 9, 2016
Last Update Posted : March 2, 2022
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Sponsor:
Revalesio Corporation
Information provided by (Responsible Party):
Revalesio Corporation
- Study Details
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Brief Summary:
The purpose of this study is to determine whether nebulized RNS60 is effective in the treatment of amyotrophic lateral sclerosis (ALS).
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Amyotrophic Lateral Sclerosis | Drug: RNS60 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis |
Estimated Study Start Date : | November 2022 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | June 2024 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Amyotrophic lateral sclerosis
Juvenile primary lateral sclerosis
MedlinePlus related topics:
Amyotrophic Lateral Sclerosis
Arm | Intervention/treatment |
---|---|
Experimental: RNS60
Nebulized RNS60 will be administered by daily inhalation for 24 weeks.
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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.
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Drug: Placebo
Nebulized Placebo will be administered by daily inhalation for 24 weeks. |
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
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
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
No Contacts or Locations Provided
Responsible Party: | Revalesio Corporation |
ClinicalTrials.gov Identifier: | NCT02988297 |
Other Study ID Numbers: |
06.2.1.H6 |
First Posted: | December 9, 2016 Key Record Dates |
Last Update Posted: | March 2, 2022 |
Last Verified: | February 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis Pathologic Processes Neurodegenerative Diseases Nervous System Diseases Neuromuscular Diseases Spinal Cord Diseases Central Nervous System Diseases TDP-43 Proteinopathies Proteostasis Deficiencies |
Metabolic Diseases RNS60 Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Pharmaceutical Solutions |