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StrokePhase 2GMAISNCT01221246

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

A Phase 2 study testing GM602 in people with Stroke, run by Genervon Biopharmaceuticals, LLC at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Stroke
What is being tested?
GM602
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
8 sitesUnited States
Study dates
8 Mar 2011to 7 Jul 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • University Erlanger Hospital

    Chattanooga, Tennessee, 37403

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

    Los Angeles, California, 90095

  • University of Louisville

    Louisville, Kentucky, 40202

  • Columbia University Medical Center

    New York, New York, 10032

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92658

  • Huntington Memorial Hospital Stroke Center

    Pasadena, California, 91105

  • California Pacific Medical Center Research Institute

    San Francisco, California, 94107

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
GM602, Placebo Comparator
Keywords
Acute Middle Cerebral Artery Ischemic Stroke within 18 hours
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GM602Drug

    Also called GM6, GM604, GM608, MNTF

    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 ComparatorDrug

    Also called Bacteriostatic saline

    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.

Study groups in NCT01221246
Study groupRoleWhat they receive
GM602ExperimentalFirst 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.
Receives: Drug: GM602
Placebo ComparatorPlacebo comparatorFirst 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.
Receives: Drug: Placebo Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 90

Secondary outcomes (6)

  1. 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

    Percent change in NIHSS from baseline to 30 days in patients treated with any active dose of GM602 compared with placebo

    Measured: Day 30

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

    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.

    Measured: Day 90

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

    Percent change in BI from baseline to 30 days in patients treated with any active dose of GM602 compared with placebo

    Measured: Day 30

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

    compared with placebo at each modified Rankin Scale (mRS) level at 90 days.

    Measured: Day 90

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

    compared with placebo at each modified Rankin Scale (mRS) level at 30 days.

    Measured: Day 30

  6. Secondary safety endpoint as measured by all cause mortality data through 3 months for patients treated with GM602 compared with placebo

    all cause mortality data through 3 months

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2010 (estimated)
  2. Study start8 Mar 2011
  3. Primary completion7 Jul 2016
  4. Study completion7 Jul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221246
Sponsor's protocol ID
GEN-002
Acronym
GMAIS
Status last verified
Jul 2019
First submitted
11 Oct 2010
Last updated
12 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GM602 in people with Stroke, run by Genervon Biopharmaceuticals, LLC at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01221246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.

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