Glyburide (RP-1127) for Traumatic Brain Injury (TBI)

April 26, 2024 updated by: Remedy Pharmaceuticals, Inc.

A Randomized Clinical Trial of Glyburide (RP-1127) for TBI

The primary objectives of this study are to assess whether participants with traumatic brain injury (TBI) administered glyburide begun within 10 hours of injury will show a decrease in magnetic resonance imaging (MRI)-defined edema and/or hemorrhage, compared to placebo and to assess the safety and tolerability of glyburide compared to placebo in participants with TBI. The secondary objectives include analyzing brain cell loss, computerized tomography (CT) scan /MRI abnormalities, reduction of mortality and or improvement of function or physiology, incidence of decompression craniectomy, incidence of neuroworsening, and to assess the steady state concentrations of glyburide in TBI participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study was previously posted by Remedy Pharmaceuticals, Inc. and has since been acquired by Biogen.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • University of California, San Diego
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center, Shock Trauma Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • UPMC Presbyterian Hospital
    • Virginia
      • Richmond, Virginia, United States, 23298
        • VCU Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Documented closed head TBI
  2. Clearly defined time of injury no more than 10 hours before administration of study drug/placebo
  3. GCS 4-14. The GCS will be obtained free of the effects of sedating and/or paralytic drug. Complicated mild must have GCS 13-14 and one or more of the following: Intraparenchymal clots or contusions in aggregate > 10cc; Midline shift > 5mm; IVH, SDH, EDH seen on more than one CT scan slice.
  4. Age 18-75 years
  5. Patients in whom a dedicated peripheral IV line can be placed for study drug administration
  6. Written consent obtained from legally authorized representative (LAR)

Exclusion Criteria:

  1. No documented TBI or time of impact not certain
  2. Penetrating brain injury
  3. Spinal column instability and/or spinal cord injury with neurodeficit
  4. Concomitant severe non survivable injury
  5. Pregnant, or a positive pregnancy test
  6. Women who intend to breastfeed during Study Days 1-4.
  7. Blood glucose <50mg/dL
  8. Severe renal disorder from the patient's history (e.g. dialysis) or serum creatinine of > 2.5 mg/dL
  9. Severe liver disease or total bilirubin >1.5 times upper limit of normal
  10. INR>1.4
  11. Systolic BP<90 mm Hg not responsive to fluid resuscitation
  12. Blood alcohol > 250mg/dL
  13. Inability to have MRI (pacemaker, non-MR compatible pressure monitor, etc.)
  14. Hospitalization for brain injury, psychiatric or neurological disease within previous 3 years
  15. Emergent or urgent surgical operation anticipated (in OR, bedside procedures excluded) that would prevent dosing with study drug within 8 hours of injury.
  16. Known use of Coumadin (warfarin), Plavix (clopidogrel), Effient (prasugrel) or Pletal (cilostazol), heparin, low molecular weight heparin, heparinoids, or abciximab or similar antiplatelet agents in the previous 72 hours (Note that patients later found to have taken these medications will not be automatically excluded from the study.)
  17. Use of sulfonylurea drugs within the prior 30 days
  18. Treatment with another investigational drug within the prior 30 days
  19. Allergy to sulfonylurea drugs
  20. Known diagnosis of G6PD enzyme deficiency
  21. PaO2 < 60 mm Hg on admission (for patients in whom blood gases are drawn per standard of care)
  22. Non-English speaking legally authorized representative and subjects (University of Maryland only)
  23. Prisoners or others who may be unable to make a truly voluntary and uncoerced decision whether or not to participate in the study
  24. Any other clinical condition which in the opinion of the investigator makes the patient unsuitable for inclusion into the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Glyburide
Glyburide delivered by injection as an approximately 2 minute loading dose followed by 72 hours of continuous infusion.
Drug: Glyburide
Administered as specified in the Treatment Arm.
Other Names:
  • RP-1127
  • glibenclamide
  • glybenclamide
Placebo Comparator: Placebo
Matching placebo delivered by injection as an approximately 2 minute loading dose followed by 72 hours of continuous infusion.
Drug: Placebo
Administered as specified in the Treatment Arm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Edema
Time Frame: Baseline, Day 3, Day 90, and Day 180
To be assessed using Magnetic Resonance Imaging (MRI).
Baseline, Day 3, Day 90, and Day 180
Change from Baseline in Hemorrhage
Time Frame: Baseline, Day 3, Day 90, and Day 180
To be assessed using MRI.
Baseline, Day 3, Day 90, and Day 180
Number of Participants with Adverse Events and Serious Adverse Events
Time Frame: 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
Up to 180 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Brain Volume
Time Frame: Baseline, Day 3, Day 90, and Day 180
To be assessed using MRI.
Baseline, Day 3, Day 90, and Day 180
Number of Participants with Abnormalities Associated with Brain Swelling
Time Frame: Baseline, Day 3, Day 90, and Day 180
To be assessed using MRI and computed tomography (CT).
Baseline, Day 3, Day 90, and Day 180
Change from Baseline in Glasgow Coma Scale (GCS)
Time Frame: 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)
Baseline up to Day 7
Change from Baseline in Intracranial Pressure (ICP)
Time Frame: Baseline up to Day 7
Baseline up to Day 7
Change from Day 30 in Extended Glasgow Outcome Scale (GOS-E)
Time Frame: 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
Day 30, Day 60, Day 90, and Day 180
Number of Participants Requiring Decompression Craniectomy
Time Frame: Baseline up to Day 7
Baseline up to Day 7
Number of Participants Experiencing Neuroworsening
Time Frame: Baseline up to Day 7
Baseline up to Day 7
PK Parameter: Steady State Concentration of Glyburide
Time Frame: Baseline and 36 hours
Baseline and 36 hours
Number of All-Cause and Neurological Mortalities
Time Frame: Up to Day 180
Up to Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Remedy Pharmaceuticals, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
U.S. Army Medical Research and Development Command
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 20, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2011

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RPI 202
  • INTRuST-GLY (Other Identifier: INTRuST Clinical Consortium Coordinating Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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