A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion
NCT ID: NCT03954041
Last Updated: 2024-11-27
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
92 participants
INTERVENTIONAL
2019-10-06
2023-06-27
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
BIIB093
Administered as specified in the treatment arm.
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.
BIIB093
Administered as specified in the treatment arm.
Placebo
Participants will be administered BIIB093 matching placebo as a IV bolus followed by rapid and slow IV infusions for 96 hours.
Placebo
Administered as specified in the treatment arm.
Interventions
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BIIB093
Administered as specified in the treatment arm.
Placebo
Administered as specified in the treatment arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Remedy Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Remedy Pharmaceuticals
Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
Scottsdale Healthcare Hospitals d/b/a HonorHealth
Scottsdale, Arizona, United States
University of Arizona Medical Center
Tucson, Arizona, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
WellStar Medical Group Neurosurgery
Marietta, Georgia, United States
Goodman Campbell Brain and Spine
Carmel, Indiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Northwell Health
Manhattan, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Vidant Medical Center
Greenville, North Carolina, United States
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States
University of Cincinnati College of Medicine
Cincinnati, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Rhode Island Hospital
East Providence, Rhode Island, United States
UT Southwestern Medical Center
Dallas, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
CHU de Brest - Hôpital de la Cavale Blanche
Brest, Finistere, France
Hopital Caremeau
Nîmes, Gard, France
Groupe Hospitalier Pellegrin - Hôpital Pellegrin
Bordeaux, Gironde, France
CHU Rennes - Hôpital Pontchaillou
Rennes, Ille Et Vilaine, France
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, Puy De Dome, France
CHU Amiens - Hopital Sud
Amiens, Somme, France
Universitaetsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Neurologische Klinik Bad Neustadt/Saale
Bad Neustadt/Saale, Bavaria, Germany
Universitaetsmedizin Goettingen
Göttingen, Lower Saxony, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Schleswig, Germany
Rabin MC
Petah Tikva, Central District, Israel
Health Corporation of Galilee Medical Center
Naharya, Northern District, Israel
Chaim Sheba Medical Center
Ramat Gan, Tel Aviv, Israel
Rambam Health Care Center
Haifa, , Israel
Shaare Zedek Medical Center
Jerusalem, , Israel
Hadassah
Jerusalem, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Torrette, Ancona, Italy
ASST Monza - Ospedale San Gerardo di Monza
Monza Brianza, Milano, Italy
Azienda Ospedaliero Universitaria di Parma
Pama, Parma, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan, , Italy
Ospedale Maggiore di Novara
Novara, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino, , Italy
Kimitsu Chuo Hospital
Kisarazu-Shi, Chiba, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Nara Medical University Hospital
Kashihara-shi, Nara, Japan
Rinku General Medical Center
Izumisano, Osaka, Japan
Nippon Medical School Hospital
Bunkyō City, Tokyo-to, Japan
Yamaguchi University Hospital
Ube-Shi, Yamaguchi, Japan
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, La Coruna, Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Universitario Reina Sofia
Córdoba, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-003858-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
252BN201
Identifier Type: -
Identifier Source: org_study_id
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