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RNS60 in ALS

NCT03456882Phase 2

Key facts

Status: Completed
Start: May 2017
Primary completion: Nov 2020
Countries: 2
Sponsor: Mario Negri Institute for Pharmacological Research
Modality: Nanoparticles, Small Molecules, Device-based Delivery

Drugs: RNS60
Conditions: amyotrophic lateral sclerosis (ALS)

Overview

Phase 2, randomised, double-blind trial in amyotrophic lateral sclerosis (ALS) comparing RNS60 with Placebo (2 arms). Primary endpoints: Monocyte Chemoattractant Protein-1 at 24 weeks, Cyclophilin A at 24 weeks and 6 more. Started May 2017; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

RNS60
RNS60 IV + Inhaled + Riluzole
Placebo
Placebo IV + Inhaled + Riluzole

Endpoints

Primary

Monocyte Chemoattractant Protein-124 weeks
Cyclophilin A24 weeks
Actin-Nitrotyrosine24 weeks
3-Nitrotyrosine24 weeks
Interleukin-1724 weeks

Secondary

ALS Functional Rating Scale-Revised48 weeks
Overall Survival48 weeks
Forced Vital Capacity48 weeks
Adverse Events48 weeks
ALS Assessment Questionnaire-4048 weeks

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