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

NCT ID: NCT01221246

Last Updated: 2019-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-08
• Study Completion Date: 2016-07-07

Brief 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.

Detailed Description

Stroke is a serious and life threatening disease. About 85% of all strokes are ischemic, caused by a blood clot or plaque that blocks a blood vessel in the brain. The thrombolytic drug tissue plasminogen activator (tPA) is the only early treatment for acute ischemic stroke approved by the FDA. Treatment with tPA must be administered within three hours of the stroke onset. Furthermore, tPA treatment carries a recognized risk of bleeding in the brain. GM602 is an investigational drug that may act as a neuroprotectant in patients who have had a stroke. It is thought to stop cell death and reduce inflammation in the injured area of the brain. This study is designed to evaluate the safety and efficacy of GM602 administered intravenously to patients in three consecutive daily doses of 320 mg/dose or 480 mg/dose, the initial dose administered within 18 hours after onset of acute ischemic stroke in the Middle Cerebral artery region.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

GM602

Intervention Type: DRUG

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 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 6 moderate and 6 severe patients receive Placebo.

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

GM6; GM604; GM608; MNTF; Bacteriostatic saline

Eligibility Criteria

Inclusion Criteria

• > 18 years old
• Be eligible for MRI or CT scan
• Have suffered acute ischemic stroke in the middle cerebral artery (MCA) distribution, as verified by the Screening diffusion-weighted imaging (DWI) abnormality and Screening perfusion-weighted imaging pressure-work index (PWI ) abnormality
• Have NIH Stroke Scale (NIHSS) score total score of 9-20 inclusive at screening
• Have suffered acute ischemic stroke within 18 hours
• Have been functionally independent with a Modified Rankin Score (mRS) of 0 or 1 prior to suffering stroke
• Patients who received tPA or FDA approved mechanical device can also enroll
• completed informed consent form

Exclusion Criteria

• Have history of stroke in the past 3 months
• Cannot be evaluated using MRI/CT
• Have stroke of the brainstem or cerebellum
• Have clinical presentation consistent with acute MI by EKG criteria (STEMI) at screening
• Have hemorrhage revealed by CT or MRI scan
• Have > 1/3 MCA territory HYPER intensity as seen on MRI OR >1/3 MCA territory HYPO intensity as seen on CT
• Have blood sugar level >400 mg/DL or<50 mg/dL
• Have kidney disease, creatinine > 2.0
• Have had recent (within 90 days) serious head trauma or head trauma with loss of consciousness
• Have any prior history of seizure
• Have clinically relevant pre-existing neurological deficit (Historical Rankin score ≥ 2)
• Have any other known clinically significant medical disorder (cardiovascular, hepatic, renal, endocrine, respiratory, immunological, cancer, AIDS)
• Life expectancy of less than 6 months due to comorbid conditions
• Women of child bearing potential who are pregnant or breast-feeding or unable to practice birth control during the study period
• Have participated in any other trial of an investigational agent within 90 days prior to screening
• Informed consent cannot be obtained
• Unable to participate in study visits

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Huntington Hospital

OTHER_GOV

Sponsor Role: collaborator

Hoag Memorial Hospital Presbyterian

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

California Pacific Medical Center Research Institute

OTHER

Sponsor Role: collaborator

University Hospital Erlangen

OTHER

Sponsor Role: collaborator

Sarasota Memorial Hospital

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: collaborator

Genervon Biopharmaceuticals, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arbi G Ohanian, MD

Role: PRINCIPAL_INVESTIGATOR

Huntington Memorial Hospital

Sidney Starkman, MD

Role: PRINCIPAL_INVESTIGATOR

UCLA Stroke Center

Jeff Saver, MD

Role: PRINCIPAL_INVESTIGATOR

UCLA Stroke Center

David Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Hoag Memorial Hospital Presbyterian

Stephan A Mayer, M.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Nobl Barazangi, M.D.

Role: PRINCIPAL_INVESTIGATOR

California Pacific Medical Center Research Institute

Thomas G Devlin, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Erlanger Hospital

Mauricio Concha, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sarasota Memorial Hospital

Anand Vaishnav, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

UCLA Stroke Center (Departments of Emergency Medicine and Neurology at the University of California, Los Angeles Medical Center)

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Huntington Memorial Hospital Stroke Center

Pasadena, California, United States

California Pacific Medical Center Research Institute

San Francisco, California, United States

Sarasota Memorial Hospital

Sarasota, Florida, United States

University of Louisville

Louisville, Kentucky, United States

Columbia University Medical Center

New York, New York, United States

University Erlanger Hospital

Chattanooga, Tennessee, United States

Countries

United States

Other Identifiers

GEN-002

Identifier Type: -

Identifier Source: org_study_id