Trial Outcomes & Findings for Glyburide Advantage in Malignant Edema and Stroke Pilot (NCT NCT01268683)
NCT ID: NCT01268683
Last Updated: 2024-11-22
Results Overview
The number of months to enroll 10 participants.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Day 1
Results posted on
2024-11-22
Participant Flow
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.
Participant milestones
| Measure |
RP-1127 (Glyburide for Injection)
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
RP-1127 (Glyburide for Injection)
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Glyburide Advantage in Malignant Edema and Stroke Pilot
Baseline characteristics by cohort
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
50.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1The number of months to enroll 10 participants.
Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Rate of Enrollment
|
9.6 Months
|
PRIMARY outcome
Timeframe: Day 1Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=175 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Percentage of Enrolled Participants to Screened Participants
|
5.7 Percentage of Participants
|
PRIMARY outcome
Timeframe: Day 90Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Percentage of Participants Completing 90-Day Follow-Up
|
80 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Day 3Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Percentage of Dose Reductions/ Dose Suspensions
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Day 3Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Percentage of Participants With All Four MRI Assessments Per Protocol
|
90 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Day 3Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Number of MRI Assessments Per Participant
|
3.9 Number of MRIs
Interval 3.0 to 4.0
|
PRIMARY outcome
Timeframe: Up to Day 4Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Percentage of Participants Requiring One or More Hypoglycemia Treatments
|
0 Percentage of Participants
|
PRIMARY outcome
Timeframe: Up to Day 4Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Percentage of Participants With Pre-specified Adverse Events Associated With Glyburide According to Protocol
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to Day 90Adverse 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.
Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
Adverse Events
|
10 Number of Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Serious Adverse Events
|
3 Number of Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, and Day 3Population: The number analyzed varies due to only MRIs of good quality being analyzed.
Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Infarcted Hemisphere Volume
Baseline
|
135.20 Centimeters cubed (cm^3)
Standard Deviation 27.19
|
|
Infarcted Hemisphere Volume
Day 1
|
156.78 Centimeters cubed (cm^3)
Standard Deviation 35.09
|
|
Infarcted Hemisphere Volume
Day 2
|
165.38 Centimeters cubed (cm^3)
Standard Deviation 34.17
|
|
Infarcted Hemisphere Volume
Day 3
|
181.71 Centimeters cubed (cm^3)
Standard Deviation 33.90
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, and Day 3Population: The number analyzed varies due to only MRIs of good quality being analyzed.
Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Absolute Diffusion Weighted Imaging (DWI) Lesion Volume
Baseline
|
101.76 Cm^3
Standard Deviation 22.57
|
|
Absolute Diffusion Weighted Imaging (DWI) Lesion Volume
Day 1
|
141.62 Cm^3
Standard Deviation 44.05
|
|
Absolute Diffusion Weighted Imaging (DWI) Lesion Volume
Day 2
|
152.31 Cm^3
Standard Deviation 49.26
|
|
Absolute Diffusion Weighted Imaging (DWI) Lesion Volume
Day 3
|
169.73 Cm^3
Standard Deviation 54.28
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, and Day 3 (Day 3 reported)Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Change From Baseline in DWI Lesion Volume
|
60.30 Cm^3
Standard Deviation 41.37
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, and Day 3Population: The number analyzed varies due to only MRIs of good quality being analyzed.
Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Midline Shift
Baseline
|
0.56 Millimeters (mm)
Standard Deviation 1.13
|
|
Midline Shift
Day 1
|
2.00 Millimeters (mm)
Standard Deviation 2.29
|
|
Midline Shift
Day 2
|
2.63 Millimeters (mm)
Standard Deviation 1.41
|
|
Midline Shift
Day 3
|
2.50 Millimeters (mm)
Standard Deviation 2.17
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, and Day 3Population: The number analyzed varies due to only MRIs of good quality being analyzed.
Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Ipsilateral Ventricle Volume
Baseline
|
11.78 Cm^3
Standard Deviation 5.98
|
|
Ipsilateral Ventricle Volume
Day 1
|
9.25 Cm^3
Standard Deviation 4.74
|
|
Ipsilateral Ventricle Volume
Day 2
|
8.92 Cm^3
Standard Deviation 4.30
|
|
Ipsilateral Ventricle Volume
Day 3
|
10.07 Cm^3
Standard Deviation 6.38
|
SECONDARY outcome
Timeframe: Day 1, Day 2, and Day 3Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Frequency of Hemorrhagic Events
Parenchymal Hematoma Type 1
|
0 Number of Events
|
|
Frequency of Hemorrhagic Events
Parenchymal Hematoma Type 2
|
0 Number of Events
|
|
Frequency of Hemorrhagic Events
Hemorrhagic Infarction Type 1
|
3 Number of Events
|
|
Frequency of Hemorrhagic Events
Hemorrhagic Infarction Type 2
|
8 Number of Events
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 3, and Day 7The 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).
Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
National Institute of Health Stroke Scale (NIHSS) Score
Baseline
|
17.8 Score on a Scale
Standard Deviation 5.92
|
|
National Institute of Health Stroke Scale (NIHSS) Score
Day 1
|
18.4 Score on a Scale
Standard Deviation 8.47
|
|
National Institute of Health Stroke Scale (NIHSS) Score
Day 2
|
15.6 Score on a Scale
Standard Deviation 5.42
|
|
National Institute of Health Stroke Scale (NIHSS) Score
Day 3
|
16.2 Score on a Scale
Standard Deviation 5.35
|
|
National Institute of Health Stroke Scale (NIHSS) Score
Day 7
|
13.9 Score on a Scale
Standard Deviation 5.51
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 3, and Day 7The 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)
Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Glasgow Coma Scale (GCS) Score
Baseline
|
12.5 Score on a scale
Standard Deviation 2.51
|
|
Glasgow Coma Scale (GCS) Score
Day 1
|
11.9 Score on a scale
Standard Deviation 2.64
|
|
Glasgow Coma Scale (GCS) Score
Day 2
|
12.5 Score on a scale
Standard Deviation 1.96
|
|
Glasgow Coma Scale (GCS) Score
Day 3
|
12.8 Score on a scale
Standard Deviation 2.20
|
|
Glasgow Coma Scale (GCS) Score
Day 7
|
13.5 Score on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 2, Day 3, and Day 7The 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.
Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Full Outline of UnResponsiveness (FOUR) Score
Day 1
|
14.5 Score on a Scale
Standard Deviation 2.32
|
|
Full Outline of UnResponsiveness (FOUR) Score
Day 2
|
14.6 Score on a Scale
Standard Deviation 2.27
|
|
Full Outline of UnResponsiveness (FOUR) Score
Day 3
|
14.6 Score on a Scale
Standard Deviation 1.65
|
|
Full Outline of UnResponsiveness (FOUR) Score
Day 7
|
14.8 Score on a Scale
Standard Deviation 1.99
|
|
Full Outline of UnResponsiveness (FOUR) Score
Baseline
|
15.1 Score on a Scale
Standard Deviation 1.10
|
SECONDARY outcome
Timeframe: Up to Day 90Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Number of Participants Requiring Decompressive Craniectomy (DC)
|
2 Number of Participants
|
SECONDARY outcome
Timeframe: Day 30, Day 90Population: The number analyzed varies due to participants not completing follow up.
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
Outcome measures
| Measure |
RP-1127 (Glyburide for Injection)
n=10 Participants
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Number of Participants With a Modified Rankin Scale (mRS) Score ≤ 4
Day 30
|
9 Number of Participants
|
|
Number of Participants With a Modified Rankin Scale (mRS) Score ≤ 4
Day 90
|
8 Number of Participants
|
Adverse Events
RP-1127 (Glyburide for Injection)
Serious events: 3 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
RP-1127 (Glyburide for Injection)
n=10 participants at risk
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Nervous system disorders
Brain herniation
|
10.0%
1/10 • Up to 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • Up to 90 Days
|
|
Nervous system disorders
Cerebrovascular accident
|
10.0%
1/10 • Up to 90 Days
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • Up to 90 Days
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Up to 90 Days
|
Other adverse events
| Measure |
RP-1127 (Glyburide for Injection)
n=10 participants at risk
RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
|
|---|---|
|
Nervous system disorders
Agitation
|
30.0%
3/10 • Up to 90 Days
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
10.0%
1/10 • Up to 90 Days
|
|
Psychiatric disorders
Anxiety
|
40.0%
4/10 • Up to 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
20.0%
2/10 • Up to 90 Days
|
|
Infections and infestations
Staphylococcal bacteraemia
|
10.0%
1/10 • Up to 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
20.0%
2/10 • Up to 90 Days
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Up to 90 Days
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Up to 90 Days
|
|
Investigations
Blood glucose decreased
|
10.0%
1/10 • Up to 90 Days
|
|
Eye disorders
Dry eyes
|
10.0%
1/10 • Up to 90 Days
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • Up to 90 Days
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
1/10 • Up to 90 Days
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Up to 90 Days
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • Up to 90 Days
|
|
Endocrine disorders
Hypercalcaemia
|
10.0%
1/10 • Up to 90 Days
|
|
Vascular disorders
Hypertension
|
20.0%
2/10 • Up to 90 Days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
60.0%
6/10 • Up to 90 Days
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
80.0%
8/10 • Up to 90 Days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
30.0%
3/10 • Up to 90 Days
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
40.0%
4/10 • Up to 90 Days
|
|
Nervous system disorders
Insomnia
|
10.0%
1/10 • Up to 90 Days
|
|
Metabolism and nutrition disorders
Malnutrition
|
10.0%
1/10 • Up to 90 Days
|
|
Gastrointestinal disorders
Nausea
|
40.0%
4/10 • Up to 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
10.0%
1/10 • Up to 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
10.0%
1/10 • Up to 90 Days
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Up to 90 Days
|
|
Investigations
Transaminase increased
|
10.0%
1/10 • Up to 90 Days
|
|
Infections and infestations
Urinary tract infection
|
40.0%
4/10 • Up to 90 Days
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
10.0%
1/10 • Up to 90 Days
|
|
Metabolism and nutrition disorders
Fluid overload
|
20.0%
2/10 • Up to 90 Days
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • Up to 90 Days
|
|
Cardiac disorders
Acute myocardial infarction
|
10.0%
1/10 • Up to 90 Days
|
|
Nervous system disorders
Vision blurred
|
10.0%
1/10 • Up to 90 Days
|
|
Renal and urinary disorders
Renal failure chronic
|
10.0%
1/10 • Up to 90 Days
|
|
Injury, poisoning and procedural complications
Open wound
|
10.0%
1/10 • Up to 90 Days
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
80.0%
8/10 • Up to 90 Days
|
|
General disorders
Pain
|
50.0%
5/10 • Up to 90 Days
|
|
Metabolism and nutrition disorders
Dehydration
|
10.0%
1/10 • Up to 90 Days
|
|
Nervous system disorders
Central pain syndrome
|
10.0%
1/10 • Up to 90 Days
|
|
Nervous system disorders
Cerebral haemorrhage
|
20.0%
2/10 • Up to 90 Days
|
|
Nervous system disorders
Cerebrovascular accident
|
10.0%
1/10 • Up to 90 Days
|
|
Nervous system disorders
Brain herniation
|
20.0%
2/10 • Up to 90 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • Up to 90 Days
|
|
Vascular disorders
Hypotension
|
10.0%
1/10 • Up to 90 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place