34
Participants
Start Date
March 8, 2011
Primary Completion Date
July 7, 2016
Study Completion Date
July 7, 2016
GM602
First 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 320 mg/dose of GM602 or placebo in a 2:1 ratio, then the next 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 480 mg/dose of GM602 or placebo in a 2:1 ratio. Concurrently, 18 severe patients will be randomized in the same manner. Total 12 moderate and 12 severe patients will receive GM602.
Placebo Comparator
First 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 320 mg/dose of GM602 or Matching Placebo (Bacteriostatic Saline) for GM602 in a 2:1 ratio, then the next 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 480 mg/dose of GM602 or placebo in a 2:1 ratio. Concurrently, 18 severe patients will be randomized in the same manner. Total 6 moderate and 6 severe patients will receive placebo.
Columbia University Medical Center, New York
Sarasota Memorial Hospital, Sarasota
University Erlanger Hospital, Chattanooga
University of Louisville, Louisville
UCLA Stroke Center (Departments of Emergency Medicine and Neurology at the University of California, Los Angeles Medical Center), Los Angeles
Huntington Memorial Hospital Stroke Center, Pasadena
Hoag Memorial Hospital Presbyterian, Newport Beach
California Pacific Medical Center Research Institute, San Francisco
Lead Sponsor
Collaborators (1)
University of California, Los Angeles
OTHER
Huntington Hospital
OTHER_GOV
Hoag Memorial Hospital Presbyterian
OTHER
Columbia University
OTHER
California Pacific Medical Center Research Institute
OTHER
University Hospital Erlangen
OTHER
Sarasota Memorial Hospital
OTHER
University of Louisville
OTHER
Genervon Biopharmaceuticals, LLC
INDUSTRY