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

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

June 21, 2017

Study Completion Date

October 18, 2017

Conditions
ALS
Interventions
DRUG

RNS60

"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."

Trial Locations (1)

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
lead

Sabrina Paganoni, M.D.

OTHER

NCT02525471 - A Pilot Study of RNS60 in Amyotrophic Lateral Sclerosis (ALS) | Biotech Hunter | Biotech Hunter