Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within 18 Hours

Summary

The purpose of this research study is to determine whether the investigational drug GM602, is effective and safe in the treatment of ischemic stroke (strokes caused by a blood clot blocking the flow of blood through one, or more of the blood vessels supplying the brain) when administered up to 18 hours after symptoms begin.

Conditions

• Stroke

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• University of California, Los Angeles

  collaborator OTHER

• Huntington Hospital

  collaborator OTHER_GOV

• Hoag Memorial Hospital Presbyterian

  collaborator OTHER

• Columbia University

  collaborator OTHER

• California Pacific Medical Center Research Institute

  collaborator OTHER

• University Hospital Erlangen

  collaborator OTHER

• Sarasota Memorial Hospital

  collaborator OTHER

• University of Louisville

  collaborator OTHER

• Genervon Biopharmaceuticals, LLC

  lead INDUSTRY

Principal Investigators

• Arbi G Ohanian, MD · Huntington Memorial Hospital

• Sidney Starkman, MD · UCLA Stroke Center

• Jeff Saver, MD · UCLA Stroke Center

• David Brown, MD · Hoag Memorial Hospital Presbyterian

• Stephan A Mayer, M.D. · Columbia University

• Nobl Barazangi, M.D. · California Pacific Medical Center Research Institute

• Thomas G Devlin, M.D. · University Erlanger Hospital

• Mauricio Concha, M.D. · Sarasota Memorial Hospital

• Anand Vaishnav, M.D. · University of Louisville

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-08

Primary Completion

2016-07-07

Completion

2016-07-07

Countries

• United States

Study Locations