Trial · NCT01268683
Glyburide Advantage in Malignant Edema and Stroke Pilot
NCT01268683, Phase 1, Phase 2, Completed, Remedy Pharmaceuticals, Inc.; results first posted 2014-06-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glyburide Advantage in Malignant Edema and Stroke Pilot. Trials, record NCT01268683. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01268683
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glyburide Advantage in Malignant Edema and Stroke Pilot
- NCT number
- NCT01268683
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Remedy Pharmaceuticals, Inc.
- Conditions
- Ischemic Stroke
- Interventions
- Glyburide for Injection
- First posted
- 2010-12-31
- Last updated
- 2024-11-22
- Results first posted
- 2014-06-06
- Limitations and caveats
- The trial was a single arm; there is thus no placebo to compare RP-1127 to.
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Enrollment | Day 1 | The number of months to enroll 10 participants. |
| Primary | Percentage of Enrolled Participants to Screened Participants | Day 1 | |
| Primary | Percentage of Participants Completing 90-Day Follow-Up | Day 90 | |
| Primary | Percentage of Dose Reductions/ Dose Suspensions | Up to Day 3 | |
| Primary | Percentage of Participants With All Four MRI Assessments Per Protocol | Up to Day 3 | |
| Primary | Number of MRI Assessments Per Participant | Up to Day 3 | |
| Primary | Percentage of Participants Requiring One or More Hypoglycemia Treatments | Up to Day 4 | |
| Primary | Percentage of Participants With Pre-specified Adverse Events Associated With Glyburide According to Protocol | Up to Day 4 | |
| Secondary | Number of Participants With Adverse Events and Serious Adverse Events | 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. |
| Secondary | Infarcted Hemisphere Volume | Baseline, Day 1, Day 2, and Day 3 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Enrollment | Day 1 | Months | NUMBER | |
| PRIMARY | Percentage of Enrolled Participants to Screened Participants | Day 1 | Percentage of Participants | NUMBER | |
| PRIMARY | Percentage of Participants Completing 90-Day Follow-Up | Day 90 | Percentage of Participants | NUMBER | |
| PRIMARY | Percentage of Dose Reductions/ Dose Suspensions | Up to Day 3 | Percentage of Participants | NUMBER | |
| PRIMARY | Percentage of Participants With All Four MRI Assessments Per Protocol | Up to Day 3 | Percentage of Participants | NUMBER | |
| PRIMARY | Number of MRI Assessments Per Participant | Up to Day 3 | Number of MRIs | MEAN | |
| PRIMARY | Percentage of Participants Requiring One or More Hypoglycemia Treatments | Up to Day 4 | Percentage of Participants | NUMBER | |
| PRIMARY | Percentage of Participants With Pre-specified Adverse Events Associated With Glyburide According to Protocol | Up to Day 4 | Percentage of Participants | NUMBER | |
| SECONDARY | Number of Participants With Adverse Events and Serious Adverse Events | Up to Day 90 | Number of Participants | NUMBER | |
| SECONDARY | Infarcted Hemisphere Volume | Baseline, Day 1, Day 2, and Day 3 | The number analyzed varies due to only MRIs of good quality being analyzed. | Centimeters cubed (cm^3) | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group49
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Enrollment | RP-1127 (Glyburide for Injection) | 9.6 | Months | ||
| Percentage of Enrolled Participants to Screened Participants | RP-1127 (Glyburide for Injection) | 5.7 | Percentage of Participants | ||
| Percentage of Participants Completing 90-Day Follow-Up | RP-1127 (Glyburide for Injection) | 80 | Percentage of Participants | ||
| Percentage of Dose Reductions/ Dose Suspensions | RP-1127 (Glyburide for Injection) | 0 | Percentage of Participants | ||
| Percentage of Participants With All Four MRI Assessments Per Protocol | RP-1127 (Glyburide for Injection) | 90 | Percentage of Participants | ||
| Number of MRI Assessments Per Participant | RP-1127 (Glyburide for Injection) | 3.9 | Full Range 3 to 4 | Number of MRIs | |
| Percentage of Participants Requiring One or More Hypoglycemia Treatments | RP-1127 (Glyburide for Injection) | 0 | Percentage of Participants | ||
| Percentage of Participants With Pre-specified Adverse Events Associated With Glyburide According to Protocol | RP-1127 (Glyburide for Injection) | 0 | Percentage of Participants | ||
| Number of Participants With Adverse Events and Serious Adverse Events | RP-1127 (Glyburide for Injection) | Adverse Events | 10 | Number of Participants | |
| Number of Participants With Adverse Events and Serious Adverse Events | RP-1127 (Glyburide for Injection) | Serious Adverse Events | 3 | Number of Participants |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | RP-1127 (Glyburide for Injection) | 10 | |
| Overall Study | COMPLETED | RP-1127 (Glyburide for Injection) | 8 | |
| Overall Study | NOT COMPLETED | RP-1127 (Glyburide for Injection) | 2 |
Source ClinicalTrials.gov
Adverse events49
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Agitation | Nervous system disorders | RP-1127 (Glyburide for Injection) | 3 | 10 | |
| other | Alcohol withdrawal syndrome | Psychiatric disorders | RP-1127 (Glyburide for Injection) | 1 | 10 | |
| other | Anxiety | Psychiatric disorders | RP-1127 (Glyburide for Injection) | 4 | 10 | |
| other | Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | RP-1127 (Glyburide for Injection) | 2 | 10 | |
| other | Staphylococcal bacteraemia | Infections and infestations | RP-1127 (Glyburide for Injection) | 1 | 10 | |
| other | Bronchospasm | Respiratory, thoracic and mediastinal disorders | RP-1127 (Glyburide for Injection) | 2 | 10 | |
| other | Constipation | Gastrointestinal disorders | RP-1127 (Glyburide for Injection) | 2 | 10 | |
| other | Depression | Psychiatric disorders | RP-1127 (Glyburide for Injection) | 1 | 10 | |
| other | Blood glucose decreased | Investigations | RP-1127 (Glyburide for Injection) | 1 | 10 | |
| other | Dry eyes | Eye disorders | RP-1127 (Glyburide for Injection) | 1 | 10 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | RP-1127 (Glyburide for Injection) | 1 | 10 |
| Total, other adverse events | RP-1127 (Glyburide for Injection) | 10 | 10 |
| Total, serious adverse events | RP-1127 (Glyburide for Injection) | 3 | 10 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01268683
GET https://conductscience.org/api/trials/v1/NCT01268683/results?page=2