Traumatic Brain InjuryPhase 2NCT01454154
Glyburide (RP-1127) for Traumatic Brain Injury (TBI)
A Phase 2 study testing Glyburide in people with Traumatic Brain Injury, run by Remedy Pharmaceuticals, Inc. at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Glyburide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Dec 2011to 20 Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented closed head TBI
- Clearly defined time of injury no more than 10 hours before administration of study drug/placebo
- 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.
- Age 18-75 years
- Patients in whom a dedicated peripheral IV line can be placed for study drug administration
- Written consent obtained from legally authorized representative (LAR)
Who cannot join
- No documented TBI or time of impact not certain
- Penetrating brain injury
- Spinal column instability and/or spinal cord injury with neurodeficit
- Concomitant severe non survivable injury
- Pregnant, or a positive pregnancy test
- Women who intend to breastfeed during Study Days 1-4.
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- Blood glucose <50mg/dL
- Severe renal disorder from the patient's history (e.g. dialysis) or serum creatinine of > 2.5 mg/dL
- Severe liver disease or total bilirubin >1.5 times upper limit of normal
- INR>1.4
- Systolic BP<90 mm Hg not responsive to fluid resuscitation
- Blood alcohol > 250mg/dL
- Inability to have MRI (pacemaker, non-MR compatible pressure monitor, etc.)
- Hospitalization for brain injury, psychiatric or neurological disease within previous 3 years
- Emergent or urgent surgical operation anticipated (in OR, bedside procedures excluded) that would prevent dosing with study drug within 8 hours of injury.
- 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.)
- Use of sulfonylurea drugs within the prior 30 days
- Treatment with another investigational drug within the prior 30 days
- Allergy to sulfonylurea drugs
- Known diagnosis of G6PD enzyme deficiency
- PaO2 < 60 mm Hg on admission (for patients in whom blood gases are drawn per standard of care)
- Non-English speaking legally authorized representative and subjects (University of Maryland only)
- Prisoners or others who may be unable to make a truly voluntary and uncoerced decision whether or not to participate in the study
- Any other clinical condition which in the opinion of the investigator makes the patient unsuitable for inclusion into the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland Medical Center, Shock Trauma Center
Baltimore, Maryland, 21201
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
VCU Medical Center
Richmond, Virginia, 23298
University of California, San Diego
San Diego, California, 92103
About this study
Official title: 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- Glyburide, Placebo
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlyburideDrug
Also called RP-1127, glibenclamide, glybenclamide
Administered as specified in the Treatment Arm.
PlaceboDrug
Administered as specified in the Treatment Arm.
| Study group | Role | What they receive |
|---|---|---|
| Glyburide | Experimental | Glyburide delivered by injection as an approximately 2 minute loading dose followed by 72 hours of continuous infusion. Receives: Drug: Glyburide |
| Placebo | Placebo comparator | Matching placebo delivered by injection as an approximately 2 minute loading dose followed by 72 hours of continuous infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Edema
To be assessed using Magnetic Resonance Imaging (MRI).
Measured: Baseline, Day 3, Day 90, and Day 180
Change from Baseline in Hemorrhage
To be assessed using MRI.
Measured: Baseline, Day 3, Day 90, and Day 180
Number of Participants with Adverse Events and Serious Adverse Events
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
Measured: Up to 180 Days
Secondary outcomes (9)
Change from Baseline in Brain Volume
To be assessed using MRI.
Measured: Baseline, Day 3, Day 90, and Day 180
Number of Participants with Abnormalities Associated with Brain Swelling
To be assessed using MRI and computed tomography (CT).
Measured: Baseline, Day 3, Day 90, and Day 180
Change from Baseline in Glasgow Coma Scale (GCS)
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)
Measured: Baseline up to Day 7
Change from Baseline in Intracranial Pressure (ICP)
Measured: Baseline up to Day 7
Change from Day 30 in Extended Glasgow Outcome Scale (GOS-E)
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
Measured: Day 30, Day 60, Day 90, and Day 180
Number of Participants Requiring Decompression Craniectomy
Measured: Baseline up to Day 7
Number of Participants Experiencing Neuroworsening
Measured: Baseline up to Day 7
PK Parameter: Steady State Concentration of Glyburide
Measured: Baseline and 36 hours
Number of All-Cause and Neurological Mortalities
Measured: Up to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study start17 Dec 2011
- Primary completion20 Feb 2015
- Study completion20 Feb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Remedy Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command, INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Remedy Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01454154
- Sponsor's protocol ID
- RPI 202
- Other IDs
- INTRuST-GLY
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2011
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Glyburide (RP-1127) for TBI
- ClinicalTrials.gov ID
- NCT01454154
- Acronym / sponsor ID
- RPI 202
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Remedy Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- U.S. Army Medical Research and Development Command, INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
- Study start
- 17 Dec 2011 (actual)
- Primary completion
- 20 Feb 2015 (actual)
- Study completion
- 20 Feb 2015 (actual)
- First posted
- 18 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glyburide | Experimental | Drug: GlyburideGlyburide delivered by injection as an approximately 2 minute loading dose followed by 72 hours of continuous infusion. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo delivered by injection as an approximately 2 minute loading dose followed by 72 hours of continuous infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented closed head TBI
- Clearly defined time of injury no more than 10 hours before administration of study drug/placebo
- 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.
- Age 18-75 years
- Patients in whom a dedicated peripheral IV line can be placed for study drug administration
Key exclusion criteria (24 listed)
- No documented TBI or time of impact not certain
- Penetrating brain injury
- Spinal column instability and/or spinal cord injury with neurodeficit
- Concomitant severe non survivable injury
- Pregnant, or a positive pregnancy test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlyburideAlso: RP-1127, glibenclamide, glybenclamideAdministered as specified in the Treatment Arm. | Drug | Glyburide |
| PlaceboAdministered as specified in the Treatment Arm. | Drug | Placebo |
Primary outcome
Change from Baseline in Edema
Time frame: Baseline, Day 3, Day 90, and Day 180
To be assessed using Magnetic Resonance Imaging (MRI).
Change from Baseline in Hemorrhage
Time frame: Baseline, Day 3, Day 90, and Day 180
To be assessed using MRI.
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
9 secondary outcomes
Change from Baseline in Brain Volume
Time frame: 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
Change from Baseline in Glasgow Coma Scale (GCS)
Time frame: Baseline up to Day 7
Change from Baseline in Intracranial Pressure (ICP)
Time frame: 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
Number of Participants Requiring Decompression Craniectomy
Time frame: Baseline up to Day 7
Number of Participants Experiencing Neuroworsening
Time frame: Baseline up to Day 7
PK Parameter: Steady State Concentration of Glyburide
Time frame: Baseline and 36 hours
Number of All-Cause and Neurological Mortalities
Time frame: Up to Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Remedy Pharmaceuticals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glyburide in people with Traumatic Brain Injury, run by Remedy Pharmaceuticals, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Edema (time frame: Baseline, Day 3, Day 90, and Day 180). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.