Brain ContusionPhase 2ASTRALNCT03954041
A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion
A Phase 2 study testing BIIB093 in people with Brain Contusion, run by Remedy Pharmaceuticals, Inc. at 63 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Brain Contusion
- What is being tested?
- BIIB093
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 63 sitesin 7 countries
- Study dates
- 6 Oct 2019to 27 Jun 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.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.
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- 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.
Trial locations and contacts
63 sites in 7 countries.
63 sites in 7 countries
United States25 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
University of Maryland Medical Center
Baltimore, Maryland, 21201
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital
Boston, Massachusetts, 02114
Goodman Campbell Brain and Spine
Carmel, Indiana, 46032
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45219
UT Southwestern Medical Center
Dallas, Texas, 75390
Miami Valley Hospital
Dayton, Ohio, 45409
Rhode Island Hospital
East Providence, Rhode Island, 02915-2237
Vidant Medical Center
Greenville, North Carolina, 27834
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Northwell Health
Manhattan, New York, 11030
WellStar Medical Group Neurosurgery
Marietta, Georgia, 30060
Yale New Haven Hospital
New Haven, Connecticut, 06510
University Medical Center New Orleans
New Orleans, Louisiana, 70119
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute
Phoenix, Arizona, 85013
Oregon Health & Science University
Portland, Oregon, 97239
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298-0599
University of Utah Health
Salt Lake City, Utah, 84132
Scottsdale Healthcare Hospitals d/b/a HonorHealth
Scottsdale, Arizona, 85258
ProMedica Toledo Hospital
Toledo, Ohio, 43606
University of Arizona Medical Center
Tucson, Arizona, 85724
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157
Spain8 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universitari de Bellvitge
Barcelona, 08907
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07120
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruna, 15706
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, 36312
Israel7 sites
Rambam Health Care Center
Haifa, 3109601
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah
Jerusalem, 9112001
Health Corporation of Galilee Medical Center
Naharya, Northern District, 22100
Rabin MC
Petah Tikva, Central District, 49100
Chaim Sheba Medical Center
Ramat Gan, Tel Aviv, 5265601
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Italy7 sites
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, 20162
ASST Monza - Ospedale San Gerardo di Monza
Monza Brianza, Milano, 20900
Ospedale Maggiore di Novara
Novara, 28100
Azienda Ospedaliero Universitaria di Parma
Pama, Parma, 43126
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00137
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, 10126
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Torrette, Ancona, 60020
France6 sites
CHU Amiens - Hopital Sud
Amiens, Somme, 80054
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux, Gironde, 33076
CHU de Brest - Hôpital de la Cavale Blanche
Brest, Finistere, 29200
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, Puy De Dome, 63003
Hopital Caremeau
Nîmes, Gard, 30029
CHU Rennes - Hôpital Pontchaillou
Rennes, Ille Et Vilaine, 35033
Japan6 sites
Nippon Medical School Hospital
Bunkyō City, Tokyo-to, 113-8603
Rinku General Medical Center
Izumisano, Osaka, 598-8577
Nara Medical University Hospital
Kashihara-shi, Nara, 634-8522
Kimitsu Chuo Hospital
Kisarazu-Shi, Chiba, 292-8535
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Hyōgo, 650-0047
Yamaguchi University Hospital
Ube-Shi, Yamaguchi, 755-8505
Germany4 sites
Neurologische Klinik Bad Neustadt/Saale
Bad Neustadt/Saale, Bavaria, 97616
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, 37075
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig, 24105
About this study
Official title: A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients With Brain Contusion
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.
- Conditions
- Brain Contusion
- Being tested
- BIIB093, Placebo
- Medical subject headings
- Brain Contusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIIB093Drug
Also called Glibenclamide, CIRARA, RP 1127
Administered as specified in the treatment arm.
PlaceboDrug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| BIIB093 3 mg | Experimental | 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. Receives: Drug: BIIB093 |
| BIIB093 5 mg | Experimental | Participants will be administered BIIB093 5 mg/day as a IV bolus followed by rapid and slow IV infusions for 96 hours. Receives: Drug: BIIB093 |
| Placebo | Placebo comparator | Participants will be administered BIIB093 matching placebo as a IV bolus followed by rapid and slow IV infusions for 96 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline up to 96 hours (Day 4)
Secondary outcomes (7)
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.
Measured: Day 180
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.
Measured: Day 90
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.
Measured: Day 1 (24 hours) up to Day 4 (96 hours) post-injury
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.
Measured: Baseline up to 24 hours (Day 1)
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.
Measured: Baseline up to 24 hours (Day 1)
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.
Measured: Baseline up to 96 hours (Day 4)
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.
Measured: Randomization up to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start6 Oct 2019
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Why it stopped: Early completed due to strategic considerations, not for efficacy or safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain ContusionStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Remedy Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Remedy Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954041
- Sponsor's protocol ID
- 252BN201
- Other IDs
- 2018-003858-24, 2018
- Acronym
- ASTRAL
- Status last verified
- Nov 2024
- First submitted
- 15 May 2019
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Multidose, Placebo-Controlled, Randomized, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 for Patients With Brain Contusion
- ClinicalTrials.gov ID
- NCT03954041
- Acronym / sponsor ID
- ASTRAL / 252BN201
- Conditions
- Brain Contusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early completed due to strategic considerations, not for efficacy or safety reasons.
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Remedy Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2019 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BIIB093 3 mg | Experimental | Drug: BIIB093Participants 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. |
| BIIB093 5 mg | Experimental | Drug: BIIB093Participants will be administered BIIB093 5 mg/day as a IV bolus followed by rapid and slow IV infusions for 96 hours. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will be administered BIIB093 matching placebo as a IV bolus followed by rapid and slow IV infusions for 96 hours. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (9 listed)
- 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.
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 |
|---|---|---|
| BIIB093Also: Glibenclamide, CIRARA, RP 1127Administered as specified in the treatment arm. | Drug | BIIB093 3 mg, BIIB093 5 mg |
| PlaceboAdministered as specified in the treatment arm. | Drug | Placebo |
Primary outcome
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging
Time frame: Baseline up to 96 hours (Day 4)
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).
7 secondary outcomes
Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180
Time frame: Day 180
Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90
Time frame: Day 90
Percentage of Participants Requiring Delayed Intubation
Time frame: Day 1 (24 hours) up to Day 4 (96 hours) post-injury
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging
Time frame: Baseline up to 24 hours (Day 1)
Change From Baseline in Absolute Hematoma Volume at 24 Hours
Time frame: Baseline up to 24 hours (Day 1)
Change From Baseline in Absolute Edema Volume at 96 Hours
Time frame: Baseline up to 96 hours (Day 4)
Time to All-Cause Death Through Day 90
Time frame: Randomization up to Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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
63 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIIB093 in people with Brain Contusion, run by Remedy Pharmaceuticals, Inc. at 63 sites in 7 countries.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 27 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 63 sites in United States, Spain, Israel, Italy, France and 2 more countries. 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?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging (time frame: Baseline up to 96 hours (Day 4)). 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 27 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.