Trial | NCT01221246  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Alirinetide ...

  • Study Participants

    34
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.
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 Started
Mar 08
2011
Primary Completion
Jul 07
2016
Study Completion
Jul 07
2016
Last Update
Aug 12
2019

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.

  • Other names: GM6, GM604, GM608, MNTF

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.

  • Other names: Bacteriostatic saline

GM602 Experimental

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 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.

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
No Results Posted