Glyburide Advantage in Malignant Edema and Stroke Pilot (GAMES-PILOT)
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|ClinicalTrials.gov Identifier: NCT01268683|
Recruitment Status : Completed
First Posted : December 31, 2010
Results First Posted : June 6, 2014
Last Update Posted : August 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke||Drug: Glyburide for Injection||Phase 1 Phase 2|
This is a multi-center, prospective, open label, phase IIa trial of glyburide for injection in 10 participants with a severe anterior circulation ischemic stroke who are likely to experience clinically significant brain swelling.
Participants will receive glyburide, delivered as an IV bolus followed by an IV infusion for 72 hours.
Participants will have a baseline (pretreatment) MRI scan as standard of care, and three follow up MRI scans (at 24+12 hours, 48+12 hours, and 72±12 hours). Since recanalization may have an effect on outcome, the results of vascular studies, obtained as part of standard of care and defined as CTA, MRA or catheter angiography of the head and neck, will be recorded. Additionally, clinical endpoints such as the National Institutes of Health Stroke Scale (NIHSS), Glasgow Coma Scale (GCS) and Full Outline of UnResponsiveness Score (FOUR) Score (baseline, 24±12 hour, 48±12 hour, 72±12 hour and 7±1 days) and Modified Rankin Scale (mRS) (30±5 days and 90±7 days) will be assessed. Safety parameters will be assessed through Day 7 or discharge (whichever is sooner), and then again at Day 30±5 and Day 90±7.
Study participation is expected to last 90±7 days.
This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Prospective, Open Label, Phase IIa Trial of RP-1127 (Glyburide for Injection) in Patients With a Severe Anterior Circulation Ischemic Stroke Who Are Likely to Experience Clinically Significant Brain Swelling.|
|Actual Study Start Date :||May 26, 2011|
|Actual Primary Completion Date :||June 7, 2012|
|Actual Study Completion Date :||June 7, 2012|
Experimental: Glyburide for Injection
This arm is administered a glyburide bolus followed by continuous infusion of glyburide for 72 hours
Drug: Glyburide for Injection
Administered as specified in the treatment arm.
- Rate of Enrollment [ Time Frame: Day 1 ]The number of months to enroll 10 participants.
- Percentage of Enrolled Participants to Screened Participants [ Time Frame: Day 1 ]
- Percentage of Participants Completing 90-Day Follow-Up [ Time Frame: Day 90 ]
- Percentage of Dose Reductions/ Dose Suspensions [ Time Frame: Up to Day 3 ]
- Percentage of Participants With All Four MRI Assessments Per Protocol [ Time Frame: Up to Day 3 ]
- Number of MRI Assessments Per Participant [ Time Frame: Up to Day 3 ]
- Percentage of Participants Requiring One or More Hypoglycemia Treatments [ Time Frame: Up to Day 4 ]
- Percentage of Participants With Pre-specified Adverse Events Associated With Glyburide According to Protocol [ Time Frame: Up to Day 4 ]
- Number of Participants With Adverse Events and Serious Adverse Events [ Time Frame: Up to Day 90 ]Adverse Events (AE's) of special interest (cardiac events, difficulty controlling blood sugar, liver problems, and blood disorders, including anemia) will be followed for 30 days and all Severe Adverse Events (SAE's) will be followed for 90 days. SAE's and AE's were reviewed, and the number of participants with unanticipated adverse events, or drug-related SAE's were assessed.
- Infarcted Hemisphere Volume [ Time Frame: Baseline, Day 1, Day 2, and Day 3 ]
- Absolute Diffusion Weighted Imaging (DWI) Lesion Volume [ Time Frame: Baseline, Day 1, Day 2, and Day 3 ]
- Change From Baseline in DWI Lesion Volume [ Time Frame: Baseline, Day 1, Day 2, and Day 3 (Day 3 reported) ]
- Midline Shift [ Time Frame: Baseline, Day 1, Day 2, and Day 3 ]
- Ipsilateral Ventricle Volume [ Time Frame: Baseline, Day 1, Day 2, and Day 3 ]
- Frequency of Hemorrhagic Events [ Time Frame: Day 1, Day 2, and Day 3 ]
- National Institute of Health Stroke Scale (NIHSS) Score [ Time Frame: Baseline, Day 1, Day 2, Day 3, and Day 7 ]The NIHSS is composed of 11 categories, each of which is scored between 0 and 4. A score of 0 indicates normal function, a higher score indicates more impairment. Category scores are summed to generate the total NIHSS score (possibles scores range from 0-42).
- Glasgow Coma Scale (GCS) Score [ Time Frame: Baseline, Day 1, Day 2, Day 3, and Day 7 ]The GCS is scored on a scale between 3 and 15 (3 = the worst, and 15 = best). It is composed of three parameters : Best Eye Response (scored on a scale of 1-4), Best Verbal Response (scored on a scale of 1-5), Best Motor Response (scored on a scale of 1-6)
- Full Outline of UnResponsiveness (FOUR) Score [ Time Frame: Baseline, Day 1, Day 2, Day 3, and Day 7 ]The FOUR Score is a 17-point scale (with potential scores ranging from 0 - 16). Decreasing FOUR Score is associated with worsening level of consciousness. The FOUR Score assesses four domains of neurological function: eye responses, motor responses, brainstem reflexes, and breathing pattern.
- Number of Participants Requiring Decompressive Craniectomy (DC) [ Time Frame: Up to Day 90 ]
- Number of Participants With a Modified Rankin Scale (mRS) Score ≤ 4 [ Time Frame: Day 30, Day 90 ]The mRS scale runs from 0-6, the scoring is as follows: 0 - No symptoms, 1 - No significant disability, 2 - Slight disability, 3 - Moderate disability, 4 - Moderately severe disability, 5 - Severe disability, 6 - Dead
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268683
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Study Director:||Medical Director||Biogen|