Nebulized RNS60 for the Treatment of Amyotrophic Lateral Sclerosis

Trial ID: NCT02988297

Interventional - Phase 2 - Withdrawn

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

Conditions

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

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

Revalesio Corporation