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

Completed

Phase 2 Results N/A

Trial Description

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

Interventions

  • GM602 Drug
    Other Names: GM6; GM604; GM608; MNTF
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: GM602
    Description: 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.
  • Matching Placebo (Bacteriostatic Saline) for GM602 Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Matching Placebo (Bacteriostatic Saline)
    Description: 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.
  • Placebo Comparator Device
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Placebo Comparator
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 Day 90 No
Primary Compare the safety and tolerability of GM602 with placebo in a population of patients with moderate to severe impairment following acute ischemic stroke as primary safety endpoint. Day 90 Yes
Secondary 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 Day 30 No
Secondary Functional Outcome as measured by the difference in percent change in Barthel Index (BI) from baseline to 90 days in patients treated with GM602 compared to treated with placebo Day 90 No
Secondary Functional Outcome as measured by the difference in percent change in Barthel Index (BI) from baseline to 30 days in patients treated with GM602 compared to treated with placebo Day 30 No
Secondary Efficacy as measured by Proportion of patients treated with any active dose of GM602 compared with placebo at each mRS level at 90 days Day 90 No
Secondary Efficacy as measured by Proportion of patients treated with any active dose of GM602 compared with placebo at each mRS level at 30 days Day 30 No
Secondary Secondary safety endpoint as measured by all cause mortality data through 3 months for patients treated with GM602 compared with placebo Day 90 Yes
Secondary Percent change in Barthel Index (BI) from baseline to 90 days in patients treated with GM602 compared to treated with placebo Day 90
Secondary Percent change in Barthel Index (BI) from baseline to 30 days in patients treated with GM602 compared to treated with placebo Day 30
Secondary Proportion of patients treated with any active dose of GM602 compared with placebo at each mRS level at 90 days Day 90
Secondary Proportion of patients treated with any active dose of GM602 compared with placebo at each mRS level at 30 days Day 30

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