A pilot trial of RNS60 in amyotrophic lateral sclerosis.

ABSTRACT:

Introduction

RNS60 is a novel immune-modulatory agent that has shown neuroprotective effects in amytrophic lateral sclerosis (ALS) preclinical models. RNS60 is administered by weekly intravenous infusion and daily nebulization. The objective of this pilot open-label trial was to test the feasibility, safety, and tolerability of long-term RNS60 administration in ALS patients.

Methods

The planned treatment duration was 23 weeks and the primary outcomes were safety and tolerability. Secondary outcomes included PBR28 positron emission tomography (PET) imaging and plasma biomarkers of inflammation.

Results

Sixteen participants with ALS received RNS60 and 13 (81%) completed 23 weeks of RNS60 treatment. There were no serious adverse events and no participants withdrew from t

SUBMITTER: Paganoni S 

PROVIDER: S-EPMC6379136 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature