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

NCT01221246 | Completed Phase 2

• 1 other identifier: GEN-002
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 8

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.

Conditions

Stroke

Keywords

Acute Middle Cerebral Artery Ischemic Stroke within 18 hours

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Day 90

Secondary Outcomes (6)

• 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

• Percent change in Barthel Index (BI) from baseline to 90 days in patients treated with GM602 compared to treated with placebo

  Day 90

• Percent change in Barthel Index (BI) from baseline to 30 days in patients treated with GM602 compared to treated with placebo

  Day 30

• Proportion of patients treated with any active dose of GM602 compared with placebo at each mRS level at 90 days

  Day 90

• Proportion of patients treated with any active dose of GM602 compared with placebo at each mRS level at 30 days

  Day 30

Other Outcomes (1)

• Primary Safety Endpoints

  througyh 3 months

Study Arms (2)

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.

Drug: 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.

Drug: Placebo Comparator

Interventions

GM602 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.

Also known as: GM6, GM604, GM608, MNTF

GM602

Placebo Comparator 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.

Also known as: Bacteriostatic saline

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genervon Biopharmaceuticals, LLC: lead
• University of California, Los Angeles: collaborator
• Huntington Hospital: collaborator
• Hoag Memorial Hospital Presbyterian: collaborator
• Columbia University: collaborator
• California Pacific Medical Center Research Institute: collaborator
• University Hospital Erlangen: collaborator
• Sarasota Memorial Hospital: collaborator
• University of Louisville: collaborator

Study Sites (8)

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

Los Angeles, California, 90095, United States

Location

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92658, United States

Location

Huntington Memorial Hospital Stroke Center

Pasadena, California, 91105, United States

Location

California Pacific Medical Center Research Institute

San Francisco, California, 94107, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

University Erlanger Hospital

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2010
• First Posted: October 14, 2010
• Study Start: March 8, 2011
• Primary Completion: July 7, 2016
• Study Completion: July 7, 2016
• Last Updated: August 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)