Clinical trial NCT03954041: A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Brain Contusion
Lead sponsor: Remedy Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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* In the judgment of the Investigator, participant is likely to have supportive care withdrawn within 24 hours.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.

Primary outcomes:
measure: Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging
timeFrame: Baseline up to 96 hours (Day 4)
Secondary outcomes:
measure: Percentage of Participants With Glasgow Outcome Scale - Extended (GOS-E) Score at Day 180
timeFrame: Day 180
measure: Percentage of Participants With Modified Rankin Scale (mRS) Score at Day 90
timeFrame: Day 90
measure: Percentage of Participants Requiring Delayed Intubation
timeFrame: Day 1 (24 hours) up to Day 4 (96 hours) post-injury
measure: Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging
timeFrame: Baseline up to 24 hours (Day 1)
measure: Change From Baseline in Absolute Hematoma Volume at 24 Hours
timeFrame: Baseline up to 24 hours (Day 1)
measure: Change From Baseline in Absolute Edema Volume at 96 Hours
timeFrame: Baseline up to 96 hours (Day 4)
measure: Time to All-Cause Death Through Day 90
timeFrame: Randomization up to Day 90
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare Hospitals d/b/a HonorHealth
state: Arizona
city: Tucson
country: United States
facility: University of Arizona Medical Center
state: Arizona
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Marietta
country: United States
facility: WellStar Medical Group Neurosurgery
state: Georgia
city: Carmel
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Manhattan
country: United States
facility: Northwell Health
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Greenville
country: United States
facility: Vidant Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Brest
country: France
facility: CHU de Brest - Hôpital de la Cavale Blanche
state: Finistere
city: Nimes Cedex 9
country: France
facility: Hopital Caremeau
state: Gard
city: Bordeaux cedex
country: France
facility: Groupe Hospitalier Pellegrin - Hôpital Pellegrin
state: Gironde
city: Rennes
country: France
facility: CHU Rennes - Hôpital Pontchaillou
state: Ille Et Vilaine
city: Clermont Ferrand cedex 1
country: France
facility: CHU Clermont Ferrand - Hopital Gabriel Montpied
state: Puy De Dome
city: Amiens Cedex
country: France
facility: CHU Amiens - Hopital Sud
state: Somme
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
state: Baden Wuerttemberg
city: Bad Neustadt/Saale
country: Germany
facility: Neurologische Klinik Bad Neustadt/Saale
state: Bayern
city: Goettingen
country: Germany
facility: Universitaetsmedizin Goettingen
state: Niedersachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel
state: Schleswig
city: Petah Tikva
country: Israel
facility: Rabin MC
state: Central
city: Naharya
country: Israel
facility: Health Corporation of Galilee Medical Center
state: Northern
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
state: Tel Aviv
city: Haifa
country: Israel
facility: Rambam Health Care Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Torrette
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
state: Ancona
city: Monza Brianza
country: Italy
facility: ASST Monza - Ospedale San Gerardo di Monza
state: Milano
city: Pama
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
state: Parma
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
city: Novara
country: Italy
facility: Ospedale Maggiore di Novara
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Torino
country: Italy
facility: Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
city: Kisarazu-Shi
country: Japan
facility: Kimitsu Chuo Hospital
state: Chiba-Ken
city: Kobe-shi
country: Japan
facility: Kobe City Hospital Organization Kobe City Medical Center General Hospital
state: Hyogo-Ken
city: Kashihara-shi
country: Japan
facility: Nara Medical University Hospital
state: Nara-Ken
city: Izumisano-Shi
country: Japan
facility: Rinku General Medical Center
state: Osaka-Fu
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo-to
city: Ube-Shi
country: Japan
facility: Yamaguchi University Hospital
state: Yamaguchi- Ken
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases
state: Baleares
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
state: La Coruna
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Remedy Pharmaceuticals
name: Medical Director
role: STUDY_DIRECTOR
References: