Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether nebulized RNS60 is effective in the treatment of amyotrophic lateral sclerosis (ALS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Revalesio Corporation
• Treatments: RNS60

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