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Glyburide Advantage in Malignant Edema and Stroke Pilot (GAMES-PILOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01268683
Recruitment Status : Completed
First Posted : December 31, 2010
Results First Posted : June 6, 2014
Last Update Posted : August 6, 2021
Sponsor:
Collaborators:
University of Maryland, College Park
Massachusetts General Hospital
Information provided by (Responsible Party):
Biogen

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ischemic Stroke
Intervention Drug: Glyburide for Injection
Enrollment 10
Recruitment Details Between February 2011, and May 2012, ten subjects were enrolled and treated at University of Maryland and the Massachusetts General Hospital within 9.6 months at 2 sites.
Pre-assignment Details  
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Period Title: Overall Study
Started 10
Completed 8
Not Completed 2
Reason Not Completed
Lost to Follow-up             1
Death             1
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  70.0%
>=65 years
3
  30.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants
50.5
(25 to 73)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
7
  70.0%
Male
3
  30.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
 100.0%
1.Primary Outcome
Title Rate of Enrollment
Hide Description The number of months to enroll 10 participants.
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Months
9.6
2.Primary Outcome
Title Percentage of Enrolled Participants to Screened Participants
Hide Description [Not Specified]
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 175
Measure Type: Number
Unit of Measure: Percentage of Participants
5.7
3.Primary Outcome
Title Percentage of Participants Completing 90-Day Follow-Up
Hide Description [Not Specified]
Time Frame Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Percentage of Participants
80
4.Primary Outcome
Title Percentage of Dose Reductions/ Dose Suspensions
Hide Description [Not Specified]
Time Frame Up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Percentage of Participants
0
5.Primary Outcome
Title Percentage of Participants With All Four MRI Assessments Per Protocol
Hide Description [Not Specified]
Time Frame Up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Percentage of Participants
90
6.Primary Outcome
Title Number of MRI Assessments Per Participant
Hide Description [Not Specified]
Time Frame Up to Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Mean (Full Range)
Unit of Measure: Number of MRIs
3.9
(3 to 4)
7.Primary Outcome
Title Percentage of Participants Requiring One or More Hypoglycemia Treatments
Hide Description [Not Specified]
Time Frame Up to Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Percentage of Participants
0
8.Primary Outcome
Title Percentage of Participants With Pre-specified Adverse Events Associated With Glyburide According to Protocol
Hide Description [Not Specified]
Time Frame Up to Day 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Percentage of Participants
0
9.Secondary Outcome
Title Number of Participants With Adverse Events and Serious Adverse Events
Hide Description 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.
Time Frame Up to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Number of Participants
Adverse Events 10
Serious Adverse Events 3
10.Secondary Outcome
Title Infarcted Hemisphere Volume
Hide Description [Not Specified]
Time Frame Baseline, Day 1, Day 2, and Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed varies due to only MRIs of good quality being analyzed.
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Centimeters cubed (cm^3)
Baseline Number Analyzed 10 participants
135.20  (27.19)
Day 1 Number Analyzed 9 participants
156.78  (35.09)
Day 2 Number Analyzed 8 participants
165.38  (34.17)
Day 3 Number Analyzed 7 participants
181.71  (33.90)
11.Secondary Outcome
Title Absolute Diffusion Weighted Imaging (DWI) Lesion Volume
Hide Description [Not Specified]
Time Frame Baseline, Day 1, Day 2, and Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed varies due to only MRIs of good quality being analyzed.
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Cm^3
Baseline Number Analyzed 9 participants
101.76  (22.57)
Day 1 Number Analyzed 9 participants
141.62  (44.05)
Day 2 Number Analyzed 8 participants
152.31  (49.26)
Day 3 Number Analyzed 6 participants
169.73  (54.28)
12.Secondary Outcome
Title Change From Baseline in DWI Lesion Volume
Hide Description [Not Specified]
Time Frame Baseline, Day 1, Day 2, and Day 3 (Day 3 reported)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Cm^3
60.30  (41.37)
13.Secondary Outcome
Title Midline Shift
Hide Description [Not Specified]
Time Frame Baseline, Day 1, Day 2, and Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed varies due to only MRIs of good quality being analyzed.
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Millimeters (mm)
Baseline Number Analyzed 9 participants
0.56  (1.13)
Day 1 Number Analyzed 9 participants
2.00  (2.29)
Day 2 Number Analyzed 8 participants
2.63  (1.41)
Day 3 Number Analyzed 6 participants
2.50  (2.17)
14.Secondary Outcome
Title Ipsilateral Ventricle Volume
Hide Description [Not Specified]
Time Frame Baseline, Day 1, Day 2, and Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed varies due to only MRIs of good quality being analyzed.
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Cm^3
Baseline Number Analyzed 9 participants
11.78  (5.98)
Day 1 Number Analyzed 9 participants
9.25  (4.74)
Day 2 Number Analyzed 8 participants
8.92  (4.30)
Day 3 Number Analyzed 6 participants
10.07  (6.38)
15.Secondary Outcome
Title Frequency of Hemorrhagic Events
Hide Description [Not Specified]
Time Frame Day 1, Day 2, and Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Number of Events
Hemorrhagic Infarction Type 1 3
Hemorrhagic Infarction Type 2 8
Parenchymal Hematoma Type 1 0
Parenchymal Hematoma Type 2 0
16.Secondary Outcome
Title National Institute of Health Stroke Scale (NIHSS) Score
Hide Description 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).
Time Frame Baseline, Day 1, Day 2, Day 3, and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Baseline 17.8  (5.92)
Day 1 18.4  (8.47)
Day 2 15.6  (5.42)
Day 3 16.2  (5.35)
Day 7 13.9  (5.51)
17.Secondary Outcome
Title Glasgow Coma Scale (GCS) Score
Hide Description 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)
Time Frame Baseline, Day 1, Day 2, Day 3, and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Score on a scale
Baseline 12.5  (2.51)
Day 1 11.9  (2.64)
Day 2 12.5  (1.96)
Day 3 12.8  (2.20)
Day 7 13.5  (1.58)
18.Secondary Outcome
Title Full Outline of UnResponsiveness (FOUR) Score
Hide Description 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.
Time Frame Baseline, Day 1, Day 2, Day 3, and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: Score on a Scale
Baseline 15.1  (1.10)
Day 1 14.5  (2.32)
Day 2 14.6  (2.27)
Day 3 14.6  (1.65)
Day 7 14.8  (1.99)
19.Secondary Outcome
Title Number of Participants Requiring Decompressive Craniectomy (DC)
Hide Description [Not Specified]
Time Frame Up to Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Number of Participants
2
20.Secondary Outcome
Title Number of Participants With a Modified Rankin Scale (mRS) Score ≤ 4
Hide Description 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
Time Frame Day 30, Day 90
Hide Outcome Measure Data
Hide Analysis Population Description
The number analyzed varies due to participants not completing follow up.
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description:
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
Overall Number of Participants Analyzed 10
Measure Type: Number
Unit of Measure: Number of Participants
Day 30 Number Analyzed 10 participants
9
Day 90 Number Analyzed 9 participants
8
Time Frame Up to 90 Days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RP-1127 (Glyburide for Injection)
Hide Arm/Group Description RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
All-Cause Mortality
RP-1127 (Glyburide for Injection)
Affected / at Risk (%)
Total   1/10 (10.00%) 
Hide Serious Adverse Events
RP-1127 (Glyburide for Injection)
Affected / at Risk (%)
Total   3/10 (30.00%) 
Metabolism and nutrition disorders   
Dehydration † 1  1/10 (10.00%) 
Nervous system disorders   
Brain herniation † 1  1/10 (10.00%) 
Cerebrovascular accident † 1  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory failure † 1  1/10 (10.00%) 
Vascular disorders   
Hypotension † 1  1/10 (10.00%) 
1
Term from vocabulary, MedDRA 12.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RP-1127 (Glyburide for Injection)
Affected / at Risk (%)
Total   10/10 (100.00%) 
Cardiac disorders   
Acute myocardial infarction † 1  1/10 (10.00%) 
Endocrine disorders   
Hypercalcaemia † 1  1/10 (10.00%) 
Eye disorders   
Dry eyes † 1  1/10 (10.00%) 
Gastrointestinal disorders   
Constipation † 1  2/10 (20.00%) 
Dry mouth † 1  1/10 (10.00%) 
Dysphagia † 1  1/10 (10.00%) 
Nausea † 1  4/10 (40.00%) 
General disorders   
Pyrexia † 1  1/10 (10.00%) 
Pain † 1  5/10 (50.00%) 
Infections and infestations   
Staphylococcal bacteraemia † 1  1/10 (10.00%) 
Urinary tract infection † 1  4/10 (40.00%) 
Injury, poisoning and procedural complications   
Open wound † 1  1/10 (10.00%) 
Investigations   
Blood glucose decreased † 1  1/10 (10.00%) 
Transaminase increased † 1  1/10 (10.00%) 
Metabolism and nutrition disorders   
Hyperkalemia † 1  1/10 (10.00%) 
Hypocalcemia † 1  6/10 (60.00%) 
Hypomagnesemia † 1  8/10 (80.00%) 
Hyponatremia † 1  3/10 (30.00%) 
Hypophosphatemia † 1  4/10 (40.00%) 
Malnutrition † 1  1/10 (10.00%) 
Hypovitaminosis † 1  1/10 (10.00%) 
Fluid overload † 1  2/10 (20.00%) 
Hypokalaemia † 1  8/10 (80.00%) 
Dehydration † 1  1/10 (10.00%) 
Nervous system disorders   
Agitation † 1  3/10 (30.00%) 
Headache † 1  1/10 (10.00%) 
Insomnia † 1  1/10 (10.00%) 
Vision blurred † 1  1/10 (10.00%) 
Central pain syndrome † 1  1/10 (10.00%) 
Cerebral haemorrhage † 1  2/10 (20.00%) 
Cerebrovascular accident † 1  1/10 (10.00%) 
Brain herniation † 1  2/10 (20.00%) 
Psychiatric disorders   
Alcohol withdrawal syndrome † 1  1/10 (10.00%) 
Anxiety † 1  4/10 (40.00%) 
Depression † 1  1/10 (10.00%) 
Agitation † 1  1/10 (10.00%) 
Renal and urinary disorders   
Renal failure chronic † 1  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Pneumonia aspiration † 1  2/10 (20.00%) 
Bronchospasm † 1  2/10 (20.00%) 
Acute pulmonary oedema † 1  1/10 (10.00%) 
Wheezing † 1  1/10 (10.00%) 
Respiratory failure † 1  1/10 (10.00%) 
Vascular disorders   
Hypertension † 1  2/10 (20.00%) 
Hypotension † 1  1/10 (10.00%) 
1
Term from vocabulary, MedDRA 12.0
†
Indicates events were collected by systematic assessment
The trial was a single arm; there is thus no placebo to compare RP-1127 to.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Biogen
Phone: 866-633-4636
EMail: clinicaltrials@biogen.com
Publications of Results:
Sheth KN, Kimberly WT, Elm JJ, Kent TA, Mandava P, Yoo AJ, Thomalla G, Campbell B, Donnan GA, Davis SM, Albers GW, Jacobson S, Simard JM, Stern BJ. Pilot study of intravenous glyburide in patients with a large ischemic stroke. Stroke. 2014 Jan;45(1):281-3. doi: 10.1161/STROKEAHA.113.003352. Epub 2013 Nov 5.
Other Publications:
Layout table for additonal information
Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01268683    
Other Study ID Numbers: RPI 201
First Submitted: December 29, 2010
First Posted: December 31, 2010
Results First Submitted: March 11, 2014
Results First Posted: June 6, 2014
Last Update Posted: August 6, 2021