A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS)
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.
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS
Study Type:Interventional Trial
Study Category:Drug Trial, Biomarkers/Imaging
Study Status:Active, no longer recruiting
Study Chair(s)/Principal Investigator(s):
Sabrina Paganoni, MD, PhD (Massachusetts General Hospital)
Nazem Atassi, MD (Massachusetts General Hospital)
Clinicaltrials.gov ID (11 digit #):NCT02525471
Coordinating Center Contact InformationMass General Hospital
Boston, Massachusetts 02114 United States
Full Study Summary:
Following screening visit to determine eligibility, enrolled subjects will undergo the baseline visit within 6 weeks where the first intravenous (IV) infusion of study medication, RNS60, will be administered. Study medication for inhalation use will be dispensed at this time, and again at weeks 7 and 15. Subjects will continue once a week follow ups to receive RNS60 by IV infusion, continuing inhalation use the remaining 6 days per week, for 24 weeks total. Additionally, eligible subjects will undergo PET imaging at baseline and again between weeks 18 and 23.
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 24 weeks.
Study Sponsor:MGH ALS Therapy Fund