- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01221246
Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within 18 Hours (GMAIS)
August 1, 2019 updated by: Genervon Biopharmaceuticals, LLC
A Phase 2 Double Blinded, Randomized, Placebo Controlled Dose Escalation Study to Evaluate the Efficacy and the Safety of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within an 18-hour Treatment Window
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States, 90095
- UCLA Stroke Center (Departments of Emergency Medicine and Neurology at the University of California, Los Angeles Medical Center)
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Newport Beach, California, United States, 92658
- Hoag Memorial Hospital Presbyterian
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Pasadena, California, United States, 91105
- Huntington Memorial Hospital Stroke Center
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San Francisco, California, United States, 94107
- California Pacific Medical Center Research Institute
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Florida
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Sarasota, Florida, United States, 34239
- Sarasota Memorial Hospital
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Tennessee
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Chattanooga, Tennessee, United States, 37403
- University Erlanger Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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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.
Other Names:
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Placebo Comparator: 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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Outcome as measured by the difference in percent change in NIHSS from baseline to 90 days in patients treated with GM602 within 18 hours compared to treated with placebo as primary efficacy endpoint
Time Frame: Day 90
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NIH Stroke Scale is a standardized neurological examination intended to describe the neurological deficits found in large groups of stroke patients participating in treatment trials.
Percent change from baseline in NIHSS is calculated and compared.
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Day 90
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Outcome as measured by the difference in percent change in NIHSS from baseline to 30 days in patients treated with GM602 compared to treated with placebo
Time Frame: Day 30
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Percent change in NIHSS from baseline to 30 days in patients treated with any active dose of GM602 compared with placebo
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Day 30
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Percent change in Barthel Index (BI) from baseline to 90 days in patients treated with GM602 compared to treated with placebo
Time Frame: Day 90
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The Barthel Index is measured using both historical and direct observational information.
It measures self-care and mobility and will help define the degree of residual disability.
Percent change from baseline in BI is calculated.
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Day 90
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Percent change in Barthel Index (BI) from baseline to 30 days in patients treated with GM602 compared to treated with placebo
Time Frame: Day 30
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Percent change in BI from baseline to 30 days in patients treated with any active dose of GM602 compared with placebo
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Day 30
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Proportion of patients treated with any active dose of GM602 compared with placebo at each mRS level at 90 days
Time Frame: Day 90
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compared with placebo at each modified Rankin Scale (mRS) level at 90 days.
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Day 90
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Proportion of patients treated with any active dose of GM602 compared with placebo at each mRS level at 30 days
Time Frame: Day 30
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compared with placebo at each modified Rankin Scale (mRS) level at 30 days.
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Day 30
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Secondary safety endpoint as measured by all cause mortality data through 3 months for patients treated with GM602 compared with placebo
Time Frame: Day 90
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all cause mortality data through 3 months
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Day 90
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Safety Endpoints
Time Frame: througyh 3 months
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Adverse events, Fatal intracranial hemorrhage (ICH).
nonfatal symptomatic parenchymal hemorrhage, or other symptomatic ICH, Neurological deterioration during hospitalization, Number of seizures after stroke, Respiratory compromise as observed by respiratory rate
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througyh 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Arbi G Ohanian, MD, Huntington Memorial Hospital
- Principal Investigator: Sidney Starkman, MD, UCLA Stroke Center
- Principal Investigator: Jeff Saver, MD, UCLA Stroke Center
- Principal Investigator: David Brown, MD, Hoag Memorial Hospital Presbyterian
- Principal Investigator: Stephan A Mayer, M.D., Columbia University
- Principal Investigator: Nobl Barazangi, M.D., California Pacific Medical Center Research Institute
- Principal Investigator: Thomas G Devlin, M.D., University Erlanger Hospital
- Principal Investigator: Mauricio Concha, M.D., Sarasota Memorial Hospital
- Principal Investigator: Anand Vaishnav, M.D., University of Louisville
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 8, 2011
Primary Completion (Actual)
July 7, 2016
Study Completion (Actual)
July 7, 2016
Study Registration Dates
First Submitted
October 11, 2010
First Submitted That Met QC Criteria
October 13, 2010
First Posted (Estimate)
October 14, 2010
Study Record Updates
Last Update Posted (Actual)
August 12, 2019
Last Update Submitted That Met QC Criteria
August 1, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GEN-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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