GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS)

PHASE2CompletedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

April 30, 2014

Study Completion Date

July 31, 2014

Conditions
Amyotrophic Lateral Sclerosis
Interventions
DRUG

GM604

GM604 treated group subject will receive a slow IV bolus injection (\~1min) of 6.4 mL (320mg @50 mg/mL=6.4 mL) for each dose. A total of 6 doses will be administered over two weeks (on Mondays, Wednesdays and Fridays for the first 2 weeks).

DRUG

Placebo comparator

Placebo comparator group subject will receive a slow IV bolus injection (\~1min) of 6.4 mL bacteriostatic saline for each dose. A total of 6 doses will be administered over two weeks (on Mondays, Wednesdays and Fridays for the first 2 weeks).

Trial Locations (2)

10032

Columbia Medical Center NY, New York

02114

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Columbia University

OTHER

collaborator

Massachusetts General Hospital

OTHER

lead

Genervon Biopharmaceuticals, LLC

INDUSTRY

NCT01854294 - GM604 Phase 2A Randomized Double-blind Placebo Controlled Pilot Trial in Amyotrophic Lateral Disease (ALS) | Biotech Hunter | Biotech Hunter