Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis

NCT ID: NCT02988297

Last Updated: 2025-11-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-10-31
• Study Completion Date: 2028-11-30

Brief Summary

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

RNS60

Nebulized RNS60 will be administered by daily inhalation for 24 weeks.

Group Type: EXPERIMENTAL

RNS60

Intervention Type: DRUG

Nebulized RNS60 will be administered by daily inhalation for 24 weeks.

Placebo

Nebulized Placebo will be administered by daily inhalation for 24 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Nebulized Placebo will be administered by daily inhalation for 24 weeks.

Interventions

RNS60

Nebulized RNS60 will be administered by daily inhalation for 24 weeks.

Intervention Type: DRUG

Placebo

Nebulized Placebo will be administered by daily inhalation for 24 weeks.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Revalesio Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Study Coordinator

Role: CONTACT

info@revalesio.com

253-922-2600

Other Identifiers

06.2.1.H6

Identifier Type: -

Identifier Source: org_study_id