CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
RNS60drug
Likely dose
RNS60 375mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02525471
NCT02525471Phase 1Completed
CompareCT.gov

A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS)

Sabrina Paganoni, M.D.·interventional·Posted Aug 17, 2015·Updated May 28, 2021

In Brief

A Phase 1 clinical trial evaluating RNS60 for ALS. Completed, enrolled 24 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and tolerability of RNS60 in patients with Amyotrophic lateral sclerosis (ALS). Investigators will also measure the impact of RNS60 on several markers of neuro-inflammation, measured by blood biomarkers and positron emission tomography (PET) imaging.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsALS
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 17, 2015
Enrollment StartOct 1, 2015
Primary CompletionJun 21, 2017
Study CompletionOct 18, 2017
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.9 years ago

Interventions

RNS60drug

RNS60 will be administered in two ways: by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) for 23 weeks. In addition, subjects will be given the option to continue to receive drug for approximately an additional 24 weeks, for a total of approximately 48 weeks on study drug. Study drug will be given by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) during the extension phase.