Amyotrophic Lateral SclerosisPhase 2NCT02988297
Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis
A Phase 2 study testing RNS60 in people with Amyotrophic Lateral Sclerosis, run by Revalesio Corporation.
Trial summary
The purpose of this study is to determine whether nebulized RNS60 is effective in the treatment of amyotrophic lateral sclerosis (ALS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Amyotrophic Lateral Sclerosis
- What is being tested?
- RNS60
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2028
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this study
The purpose of this study is to determine whether nebulized RNS60 is effective in the treatment of amyotrophic lateral sclerosis (ALS).
- Conditions
- Amyotrophic Lateral Sclerosis
- Being tested
- RNS60, Placebo
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNS60Drug
Nebulized RNS60 will be administered by daily inhalation for 24 weeks.
PlaceboDrug
Nebulized Placebo will be administered by daily inhalation for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| RNS60 | Experimental | Nebulized RNS60 will be administered by daily inhalation for 24 weeks. Receives: Drug: RNS60 |
| Placebo | Placebo comparator | Nebulized Placebo will be administered by daily inhalation for 24 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALS functional rating scale-revised (ALSFRS-R) score
The mean change of the ALSFRS-R total score
Measured: 24 weeks
Secondary outcomes (5)
Deaths or tracheostomies
The cumulative proportion of deaths or tracheostomies
Measured: 28 weeks
Proportion of regulatory T cells (Treg)
The mean change in the proportion of Tregs
Measured: 24 weeks
Slow vital capacity (SVC)
The mean change of the SVC score
Measured: 24 weeks
ALS assessment questionnaire (ALSAQ-40) score
The mean change of the ALS assessment questionnaire (ALSAQ-40) score
Measured: 24 weeks
Adverse events (AEs)
The mean number of AEs
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startOct 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Why it stopped: Withdrawn prior to initiation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revalesio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988297
- Sponsor's protocol ID
- 06.2.1.H6
- Status last verified
- Apr 2026
- First submitted
- 7 Dec 2016
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT02988297
- Acronym / sponsor ID
- 06.2.1.H6
- Conditions
- Amyotrophic Lateral Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn prior to initiation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Revalesio CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether nebulized RNS60 is effective in the treatment of amyotrophic lateral sclerosis (ALS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RNS60 | Experimental | Drug: RNS60Nebulized RNS60 will be administered by daily inhalation for 24 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboNebulized Placebo will be administered by daily inhalation for 24 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNS60Nebulized RNS60 will be administered by daily inhalation for 24 weeks. | Drug | RNS60 |
| PlaceboNebulized Placebo will be administered by daily inhalation for 24 weeks. | Drug | Placebo |
Primary outcome
ALS functional rating scale-revised (ALSFRS-R) score
Time frame: 24 weeks
The mean change of the ALSFRS-R total score
5 secondary outcomes
Deaths or tracheostomies
Time frame: 28 weeks
Proportion of regulatory T cells (Treg)
Time frame: 24 weeks
Slow vital capacity (SVC)
Time frame: 24 weeks
ALS assessment questionnaire (ALSAQ-40) score
Time frame: 24 weeks
Adverse events (AEs)
Time frame: 28 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RNS60 in people with Amyotrophic Lateral Sclerosis, run by Revalesio Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALS functional rating scale-revised (ALSFRS-R) score (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.