Trial · NCT01454154
Glyburide (RP-1127) for Traumatic Brain Injury (TBI)
NCT01454154, Phase 2, Completed, Remedy Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Glyburide (RP-1127) for Traumatic Brain Injury (TBI). Trials, record NCT01454154. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01454154
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Glyburide (RP-1127) for Traumatic Brain Injury (TBI)
- NCT number
- NCT01454154
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- Remedy Pharmaceuticals, Inc.
- Conditions
- Traumatic Brain Injury
- Interventions
- Glyburide, Placebo
- First posted
- 2011-10-18
- Last updated
- 2024-11-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in Edema | Baseline, Day 3, Day 90, and Day 180 | To be assessed using Magnetic Resonance Imaging (MRI). |
| Primary | Change from Baseline in Hemorrhage | Baseline, Day 3, Day 90, and Day 180 | To be assessed using MRI. |
| Primary | Number of Participants with Adverse Events and Serious Adverse Events | Up to 180 Days | An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that is fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event |
| Secondary | Change from Baseline in Brain Volume | Baseline, Day 3, Day 90, and Day 180 | To be assessed using MRI. |
| Secondary | Number of Participants with Abnormalities Associated with Brain Swelling | Baseline, Day 3, Day 90, and Day 180 | To be assessed using MRI and computed tomography (CT). |
| Secondary | Change from Baseline in Glasgow Coma Scale (GCS) | Baseline up to Day 7 | The GCS is scored 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) |
| Secondary | Change from Baseline in Intracranial Pressure (ICP) | Baseline up to Day 7 | |
| Secondary | Change from Day 30 in Extended Glasgow Outcome Scale (GOS-E) | Day 30, Day 60, Day 90, and Day 180 | The GOS-E assesses status in patients with traumatic brain injury on an 8-point scale. The minimum score is 1 and the maximum score is 8. The rating scale is as follows: 1- Dead, 2- Vegetative State, 3- Low Severe Disability, 4- Upper Severe Disability, 5- Low Moderate Disability, 6- Upper Moderate Disability, 7- Low Good Recovery, and 8- Upper Good Recovery |
| Secondary | Number of Participants Requiring Decompression Craniectomy | Baseline up to Day 7 | |
| Secondary | Number of Participants Experiencing Neuroworsening | Baseline up to Day 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT01454154
GET https://conductscience.org/api/trials/v1/NCT01454154/registered