ClinicalTrials.gg
Sign In
TerminatedNCT03954041ASTRALUpdated Nov 27, 2024Results posted

A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion

A Phase 2 interventional study of BIIB093 and Placebo in Brain Contusion, sponsored by Remedy Pharmaceuticals, Inc.. Terminated at 63 sites in 7 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Remedy Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Why this study was terminated
Early completed due to strategic considerations, not for efficacy or safety reasons.
Phase
Phase 2
Study type
Interventional
Enrollment
92
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The primary objective is to determine if BIIB093 reduces brain contusion expansion by Hour 96 when compared to placebo.

The secondary objectives are to evaluate the effects of BIIB093 on acute neurologic status, functional outcomes, and treatment requirements, to further differentiate the mechanism of action of BIIB093 on contusion expansion by examining differential effects on hematoma and edema expansion, and to determine if BIIB093 improves survival at Day 90 when compared to placebo.

02

Conditions studied

  • Brain Contusion
03

In context

Lead sponsor

Remedy Pharmaceuticals, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Clinical diagnosis of brain contusion with lesions within the supratentorial brain parenchyma totaling >3 mL in volume per Investigator assessment of baseline non-contrast computed tomography scan (NCCT) at Screening.
  • A score of 5 to 15 on the Glasgow Coma Scale (GCS).
  • Functionally independent, in the opinion of the Investigator, prior to index head injury.

Key Exclusion Criteria:

  • In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.
  • Indication for immediate evacuation of IPH or DC.
  • Clinical signs of brainstem herniation, in the opinion of the Investigator.
  • NCCT or magnetic resonance imaging (MRI) evidence of penetrating brain parenchyma. Cerebrospinal fluid leak in isolation is not exclusionary unless evidence of parenchymal penetration by an external force (e.g., blunt object, bullet, or depressed skull fracture).
  • Any presence of midbrain or posterior fossa injury as assessed by imaging and clinical examination.
  • Presence of concomitant spinal cord injury as assessed by imaging and clinical examination.
  • Life-threatening or nonsurvivable polytrauma, per Investigator's judgment.
  • Use of novel oral anticoagulants (NOACS; including direct thrombin inhibitors such as dabigatran, or Factor Xa inhibitors such as rivaroxaban or apixaban), in preceding 3 days prior to the injury, if known.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
92 participants (actual)

Study arms

  • Experimental
    BIIB093 3 mg

    Participants will be administered BIIB093 3 milligrams per day (mg/day) as a IV bolus followed by rapid and slow intravenous (IV) infusions for 96 hours.

    Drug: BIIB093

  • Experimental
    BIIB093 5 mg

    Participants will be administered BIIB093 5 mg/day as a IV bolus followed by rapid and slow IV infusions for 96 hours.

    Drug: BIIB093

  • Placebo comparator
    Placebo

    Participants will be administered BIIB093 matching placebo as a IV bolus followed by rapid and slow IV infusions for 96 hours.

    Drug: Placebo

Interventions

  • DrugBIIB093

    Administered as specified in the treatment arm.

    Also known as: Glibenclamide, CIRARA, RP 1127

  • DrugPlacebo

    Administered as specified in the treatment arm.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging

    Total contusion volume including hematoma and perihematomal edema volumes reported in milliliters (mL) was assessed by the central imaging core laboratory on baseline non-contrast computed tomography (NCCT), 24-hour NCCT, and the 96-hour scan (Magnetic resonance imaging \[MRI\] and/or NCCT) and the scans obtained prior to decompressive craniectomy (DC), intraparenchymal hematoma (IPH) evacuation, or comfort measures only (CMO).

    Time frame: Baseline up to 96 hours (Day 4)

Secondary outcomes

  1. Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180

    The GOS-E is a global disability scale used to assess recovery after traumatic brain injury. For this study, the 8 point ordinal scale was condensed to the following 7-categories: 1 and 2 combined: Dead and Vegetative State, 3: Lower Severe disability, 4: Upper Severe disability, 5: Lower Moderate disability, 6: Upper Moderate disability, 7 : Lower Good recovery, and 8: Upper Good Recovery. Lower scores indicate death and higher scores indicate recovery.

    Time frame: Day 180

  2. Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90

    The mRS measures the degree of functional independence following stroke. In this study, the 7-category ordinal mRS scale was condensed to the following 5-categories: 0/1, 2, 3, 4, 5/6 where 0 and 1 reflect no disability and near-normal functioning while 5 and 6 represent severe disability and death, respectively.

    Time frame: Day 90

  3. Percentage of Participants Requiring Delayed Intubation

    Delayed intubation is defined as participants requiring intubation (for neurologic deterioration only) at any time between 24 hours and 96 hours post-injury.

    Time frame: Day 1 (24 hours) up to Day 4 (96 hours) post-injury

  4. Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging

    Total contusion volume including hematoma and perihematomal edema volumes reported in mL was assessed by the central imaging core laboratory on baseline NCCT and 24-hour NCCT.

    Time frame: Baseline up to 24 hours (Day 1)

  5. Change From Baseline in Absolute Hematoma Volume at 24 Hours

    Hematoma volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the scans obtained prior to DC, IPH evacuation, or CMO.

    Time frame: Baseline up to 24 hours (Day 1)

  6. Change From Baseline in Absolute Edema Volume at 96 Hours

    Edema volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the 96-hour scan (MRI and/or NCCT) and the scans obtained prior to DC, IPH evacuation, or CMO.

    Time frame: Baseline up to 96 hours (Day 4)

  7. Time to All-Cause Death Through Day 90

    Time to all-cause death is defined as the time from randomization to the time of death and includes all-cause death along with neurological death.

    Time frame: Randomization up to Day 90

07

Results

Posted Dec 20, 2023
Limitations and caveats
Early termination of trial due to strategic considerations, not for efficacy or safety reasons.

Participant flow

Participants were enrolled at study centers in Israel, France, Japan, Italy, Spain, and the United States.

Participant flow — Overall Study
MilestonePlaceboBIIB093 3 mg/DayBIIB093 5 mg/Day
Started482321
Completed301411
Not completed18910
Withdrew: Lost to follow-up336
Withdrew: Death401
Withdrew: Death by neurologic criteria001
Withdrew: Reason not specified742
Withdrew: Withdrew prior to dosing420

Outcome measures

PrimaryChange From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging

Total contusion volume including hematoma and perihematomal edema volumes reported in milliliters (mL) was assessed by the central imaging core laboratory on baseline non-contrast computed tomography (NCCT), 24-hour NCCT, and the 96-hour scan (Magnetic resonance imaging \[MRI\] and/or NCCT) and the scans obtained prior to decompressive craniectomy (DC), intraparenchymal hematoma (IPH) evacuation, or comfort measures only (CMO).

Time frame:
Baseline up to 96 hours (Day 4)
Reported as:
Mean · mL
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging
mLPlaceboBIIB093 3 mg/DayBIIB093 5 mg/Day
Baseline29.45 ± 29.68821.21 ± 26.65921.33 ± 26.637
Change From Baseline at 96 Hours18.91 ± 23.80430.07 ± 29.41818.78 ± 12.771
Statistical analysis
  • Placebo vs BIIB093 3 mg/Day vs BIIB093 5 mg/Day · ANCOVA · p = = 0.3752 (P-value was analyzed by ANCOVA model with covariates: treatment, interactive response technology (IRT) stratification factors at randomization, baseline total contusion volume based on central read, imaging modality at Hour 96 (MRI vs NCCT).) · Ls mean difference: 4.62 · 95% CI -5.74 to 14.98
SecondaryPercentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180

The GOS-E is a global disability scale used to assess recovery after traumatic brain injury. For this study, the 8 point ordinal scale was condensed to the following 7-categories: 1 and 2 combined: Dead and Vegetative State, 3: Lower Severe disability, 4: Upper Severe disability, 5: Lower Moderate disability, 6: Upper Moderate disability, 7 : Lower Good recovery, and 8: Upper Good Recovery. Lower scores indicate death and higher scores indicate recovery.

Time frame:
Day 180
Reported as:
Number · Percentage of participants
Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180
Percentage of participantsPlaceboBIIB093 3 mg/DayBIIB093 5 mg/Day
Score: 1/2000
Score: 313.313.327.3
Score: 4026.79.1
Score: 513.36.70
Score: 626.700
Score: 76.713.327.3
Score: 840.040.036.4
Statistical analysis
  • Placebo vs BIIB093 3 mg/Day vs BIIB093 5 mg/Day · Odds ratio (or): 1.16 · 95% CI 0.40 to 3.36
SecondaryPercentage of Participants With Modified Rankin Scale (mRS) Score at Day 90

The mRS measures the degree of functional independence following stroke. In this study, the 7-category ordinal mRS scale was condensed to the following 5-categories: 0/1, 2, 3, 4, 5/6 where 0 and 1 reflect no disability and near-normal functioning while 5 and 6 represent severe disability and death, respectively.

Time frame:
Day 90
Reported as:
Number · Percentage of participants
Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90
Percentage of participantsPlaceboBIIB093 3 mg/DayBIIB093 5 mg/Day
Score: 0/138.531.657.1
Score: 225.626.37.1
Score: 312.821.10
Score: 410.315.821.4
Score: 5/612.85.314.3
Statistical analysis
  • Placebo vs BIIB093 3 mg/Day vs BIIB093 5 mg/Day · Regression, Logistic · p = =0.4306 (P-value was analyzed by ordinal logistic regression on mRS adjusting for covariates: treatment, IRT stratification factors at randomization, baseline mRS score, and baseline total contusion volume based on central read.) · Odds ratio (or): 1.47 · 95% CI 0.56 to 3.86
SecondaryPercentage of Participants Requiring Delayed Intubation

Delayed intubation is defined as participants requiring intubation (for neurologic deterioration only) at any time between 24 hours and 96 hours post-injury.

Time frame:
Day 1 (24 hours) up to Day 4 (96 hours) post-injury
Reported as:
Number · Percentage of participants
Percentage of Participants Requiring Delayed Intubation
Percentage of participantsPlaceboBIIB093 3 mg/DayBIIB093 5 mg/Day
Percentage of Participants Requiring Delayed Intubation2.34.80
SecondaryChange From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging

Total contusion volume including hematoma and perihematomal edema volumes reported in mL was assessed by the central imaging core laboratory on baseline NCCT and 24-hour NCCT.

Time frame:
Baseline up to 24 hours (Day 1)
Reported as:
Mean · mL
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging
mLPlaceboBIIB093 3 mg/DayBIIB093 5 mg/Day
Baseline29.45 ± 29.68821.21 ± 26.65921.33 ± 26.637
Change From Baseline at 24 Hours8.16 ± 18.82411.24 ± 13.9096.67 ± 13.483
Statistical analysis
  • Placebo vs BIIB093 3 mg/Day vs BIIB093 5 mg/Day · ANCOVA · p = = 0.6478 (P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline total contusion volume based on central read.) · Ls mean difference: -1.53 · 95% CI -8.19 to 5.13
SecondaryChange From Baseline in Absolute Hematoma Volume at 24 Hours

Hematoma volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the scans obtained prior to DC, IPH evacuation, or CMO.

Time frame:
Baseline up to 24 hours (Day 1)
Reported as:
Mean · mL
Change From Baseline in Absolute Hematoma Volume at 24 Hours
mLPlaceboBIIB093 3 mg/DayBIIB093 5 mg/Day
Baseline6.72 ± 10.0126.11 ± 12.0863.62 ± 3.737
Change From Baseline at 24 Hours2.07 ± 5.9202.13 ± 3.6672.23 ± 3.537
Statistical analysis
  • Placebo vs BIIB093 3 mg/Day vs BIIB093 5 mg/Day · ANCOVA · p = =0.9314 (P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline Glasgow Coma Scale (GCS) based on eCRF, and baseline absolute hematoma volume based on central read.) · Ls mean difference: -0.09 · 95% CI -2.20 to 2.02
SecondaryChange From Baseline in Absolute Edema Volume at 96 Hours

Edema volume reported in mL was assessed by the central imaging core laboratory on baseline NCCT, 24-hour NCCT, and the 96-hour scan (MRI and/or NCCT) and the scans obtained prior to DC, IPH evacuation, or CMO.

Time frame:
Baseline up to 96 hours (Day 4)
Reported as:
Mean · mL
Change From Baseline in Absolute Edema Volume at 96 Hours
mLPlaceboBIIB093 3 mg/DayBIIB093 5 mg/Day
Baseline22.41 ± 23.23415.10 ± 16.36617.52 ± 24.103
Change From Baseline at 96 Hours16.13 ± 20.87225.87 ± 27.77214.98 ± 10.459
Statistical analysis
  • Placebo vs BIIB093 3 mg/Day vs BIIB093 5 mg/Day · ANCOVA · p = = 0.6569 (P-value was analyzed by ANCOVA model with covariates: treatment, IRT stratification factors at randomization, baseline absolute edema volume based on central read, baseline GCS based on eCRF, and imaging modality at Hour 96 (MRI vs NCCT).) · Ls mean difference: 2.18 · 95% CI -7.61 to 11.98
SecondaryTime to All-Cause Death Through Day 90

Time to all-cause death is defined as the time from randomization to the time of death and includes all-cause death along with neurological death.

Time frame:
Randomization up to Day 90
Reported as:
Median · days
Time to All-Cause Death Through Day 90
daysPlaceboBIIB093 3 mg/DayBIIB093 5 mg/Day
Time to All-Cause Death Through Day 90NA (NA to NA)—NA (NA to NA)

Adverse events

Collected over From signing of informed consent up to last follow-up visit (approximately 1360 days). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo4/44 (9.1%)12/44 (27.3%)36/44 (81.8%)
BIIB093 3mg/Day0/23 (0%)7/23 (30.4%)20/23 (87%)
BIIB093 5mg/Day2/19 (10.5%)8/19 (42.1%)18/19 (94.7%)
Most frequent serious events
Showing 10 of 31
Most frequent serious events
EventPlaceboBIIB093 3mg/DayBIIB093 5mg/Day
HypoglycaemiaMetabolism and nutrition disorders0/444/234/19
Intracranial pressure increasedNervous system disorders2/440/233/19
AnaemiaBlood and lymphatic system disorders0/440/231/19
Cardiac arrestCardiac disorders1/440/231/19
Multiple organ dysfunction syndromeGeneral disorders0/440/231/19
Subdural haematomaInjury, poisoning and procedural complications2/441/231/19
Pneumonia staphylococcalInfections and infestations1/441/230/19
UrosepsisInfections and infestations0/441/230/19
Brain contusionInjury, poisoning and procedural complications1/441/230/19
Clavicle fractureInjury, poisoning and procedural complications0/441/230/19
Most frequent other events
Showing 10 of 92
Most frequent other events
EventPlaceboBIIB093 3mg/DayBIIB093 5mg/Day
HypoglycaemiaMetabolism and nutrition disorders1/447/233/19
ConstipationGastrointestinal disorders10/446/232/19
PyrexiaGeneral disorders9/446/233/19
HypokalaemiaMetabolism and nutrition disorders10/446/232/19
HyponatraemiaMetabolism and nutrition disorders6/446/231/19
HypertensionVascular disorders9/446/234/19
VomitingGastrointestinal disorders4/445/231/19
PneumoniaInfections and infestations9/443/233/19
BradycardiaCardiac disorders5/444/232/19
HeadacheNervous system disorders7/444/232/19

Baseline characteristics

All dosed population included all the randomized participants who received any study drug (BIIB093 or a placebo).

Age, Continuous
Age, Continuous(years)PlaceboBIIB093 3 mg/DayBIIB093 5 mg/DayTotal
Mean59.3 ± 14.1855.7 ± 19.8755.0 ± 21.0257.4 ± 17.39
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboBIIB093 3 mg/DayBIIB093 5 mg/DayTotal
Female83314
Male36181872
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboBIIB093 3 mg/DayBIIB093 5 mg/DayTotal
Hispanic or Latino2248
Not Hispanic or Latino39151468
Unknown or Not Reported34310
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)PlaceboBIIB093 3 mg/DayBIIB093 5 mg/DayTotal
Race — American Indian or Alaska Native1001
Race — Asian125522
Race — Black or African American1001
Race — White26121351
Race — Not Reported2439
Race — Other2002
08

Study locations

63 sites
  • Barrow Neurological Institute
    Phoenix, Arizona 85013, United States
  • Scottsdale Healthcare Hospitals d/b/a HonorHealth
    Scottsdale, Arizona 85258, United States
  • University of Arizona Medical Center
    Tucson, Arizona 85724, United States
  • Yale New Haven Hospital
    New Haven, Connecticut 06510, United States
  • Grady Memorial Hospital
    Atlanta, Georgia 30303, United States
  • WellStar Medical Group Neurosurgery
    Marietta, Georgia 30060, United States
  • Goodman Campbell Brain and Spine
    Carmel, Indiana 46032, United States
  • University Medical Center New Orleans
    New Orleans, Louisiana 70119, United States
  • University of Maryland Medical Center
    Baltimore, Maryland 21201, United States
  • Tufts Medical Center
    Boston, Massachusetts 02111, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Northwell Health
    Manhattan, New York 11030, United States
  • University of North Carolina at Chapel Hill
    Chapel Hill, North Carolina 27514, United States
  • Vidant Medical Center
    Greenville, North Carolina 27834, United States
  • Wake Forest Baptist Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • University of Cincinnati College of Medicine
    Cincinnati, Ohio 45219, United States
  • Miami Valley Hospital
    Dayton, Ohio 45409, United States
  • ProMedica Toledo Hospital
    Toledo, Ohio 43606, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • Rhode Island Hospital
    East Providence, Rhode Island 02915-2237, United States
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
  • The University of Texas Health Science Center at Houston
    Houston, Texas 77030, United States
  • University of Utah Health
    Salt Lake City, Utah 84132, United States
  • Virginia Commonwealth University Medical Center
    Richmond, Virginia 23298-0599, United States
  • CHU de Brest - Hôpital de la Cavale Blanche
    Brest, Finistere 29200, France
  • Hopital Caremeau
    Nimes Cedex 9, Gard 30029, France
  • Groupe Hospitalier Pellegrin - Hôpital Pellegrin
    Bordeaux cedex, Gironde 33076, France
  • CHU Rennes - Hôpital Pontchaillou
    Rennes, Ille Et Vilaine 35033, France
  • CHU Clermont Ferrand - Hopital Gabriel Montpied
    Clermont Ferrand cedex 1, Puy De Dome 63003, France
  • CHU Amiens - Hopital Sud
    Amiens Cedex, Somme 80054, France
  • Universitaetsklinikum Heidelberg
    Heidelberg, Baden Wuerttemberg 69120, Germany
  • Neurologische Klinik Bad Neustadt/Saale
    Bad Neustadt/Saale, Bayern 97616, Germany
  • Universitaetsmedizin Goettingen
    Goettingen, Niedersachsen 37075, Germany
  • Universitaetsklinikum Schleswig-Holstein - Campus Kiel
    Kiel, Schleswig 24105, Germany
  • Rabin MC
    Petah Tikva, Central 49100, Israel
  • Health Corporation of Galilee Medical Center
    Naharya, Northern 22100, Israel
  • Chaim Sheba Medical Center
    Ramat Gan, Tel Aviv 5265601, Israel
  • Rambam Health Care Center
    Haifa, 3109601, Israel
  • Shaare Zedek Medical Center
    Jerusalem, 9103102, Israel
  • Hadassah
    Jerusalem, 9112001, Israel
  • Tel Aviv Sourasky Medical Center
    Tel Aviv, 64239, Israel
  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
    Torrette, Ancona 60020, Italy
  • ASST Monza - Ospedale San Gerardo di Monza
    Monza Brianza, Milano 20900, Italy
  • Azienda Ospedaliero Universitaria di Parma
    Pama, Parma 43126, Italy
  • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
    Milano, 20162, Italy
  • Ospedale Maggiore di Novara
    Novara, 28100, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Roma, 00137, Italy
  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
    Torino, 10126, Italy
  • Kimitsu Chuo Hospital
    Kisarazu-Shi, Chiba-Ken 292-8535, Japan
  • Kobe City Hospital Organization Kobe City Medical Center General Hospital
    Kobe-shi, Hyogo-Ken 650-0047, Japan
  • Nara Medical University Hospital
    Kashihara-shi, Nara-Ken 634-8522, Japan
  • Rinku General Medical Center
    Izumisano-Shi, Osaka-Fu 598-8577, Japan
  • Nippon Medical School Hospital
    Bunkyo-ku, Tokyo-to 113-8603, Japan
  • Yamaguchi University Hospital
    Ube-Shi, Yamaguchi- Ken 755-8505, Japan
  • Hospital Universitari Son Espases
    Palma de Mallorca, Baleares 07120, Spain
  • Complejo Hospitalario Universitario de Santiago
    Santiago de Compostela, La Coruna 15706, Spain
  • Hospital Alvaro Cunqueiro
    Vigo, Pontevedra 36312, Spain
  • Hospital Universitari Vall d'Hebron
    Barcelona, 08035, Spain
  • Hospital Universitari de Bellvitge
    Barcelona, 08907, Spain
  • Hospital Universitario Reina Sofia
    Cordoba, 14004, Spain
  • Hospital Universitario 12 de Octubre
    Madrid, 28041, Spain
  • Hospital Universitario La Paz
    Madrid, 28046, Spain
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2019 to primary completion in Jun 2023, 44 months.

Results were first posted in Dec 2023, 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
May 15, 2019
First posted
May 17, 2019
StartActual
Oct 6, 2019
Primary completionActual
Jun 27, 2023
CompletionActual
Jun 27, 2023
Results first posted
Dec 20, 2023
Last update
Nov 27, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03954041
Lead sponsor
Remedy Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
May 17, 2019
Start date
Oct 6, 2019
Primary completion
Jun 27, 2023
Completion
Jun 27, 2023
Results posted
Dec 20, 2023
Last update
Nov 27, 2024

Study contacts

Medical Director
study director · Remedy Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Glyburide

Other studies in this condition

Brain Contusion

Other studies from this sponsor

Remedy Pharmaceuticals, Inc.

Start the discussion