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

NCT03954041 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: 252BN2012018-003858-24
• Study Type: interventional
• Target: 92
• Locations: 7 countries
• Sites: 63

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.

Conditions

Brain Contusion

Outcome Measures

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).

  Baseline up to 96 hours (Day 4)

Secondary Outcomes (7)

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

  Day 180

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

  Day 90

• Percentage of Participants Requiring Delayed Intubation

  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

  Baseline up to 24 hours (Day 1)

• Change From Baseline in Absolute Hematoma Volume at 24 Hours

  Baseline up to 24 hours (Day 1)

Study Arms (3)

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.

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.

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.

Drug: Placebo

Interventions

BIIB093 DRUG

Administered as specified in the treatment arm.

Also known as: Glibenclamide, CIRARA, RP 1127

BIIB093 3 mg; BIIB093 5 mg

Placebo DRUG

Administered as specified in the treatment arm.

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Remedy Pharmaceuticals, Inc.: lead

Study Sites (63)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

Scottsdale Healthcare Hospitals d/b/a HonorHealth

Scottsdale, Arizona, 85258, United States

Location

University of Arizona Medical Center

Tucson, Arizona, 85724, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

WellStar Medical Group Neurosurgery

Marietta, Georgia, 30060, United States

Location

Goodman Campbell Brain and Spine

Carmel, Indiana, 46032, United States

Location

University Medical Center New Orleans

New Orleans, Louisiana, 70119, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Northwell Health

Manhattan, New York, 11030, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Vidant Medical Center

Greenville, North Carolina, 27834, United States

Location

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45219, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Rhode Island Hospital

East Providence, Rhode Island, 02915-2237, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

University of Utah Health

Salt Lake City, Utah, 84132, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298-0599, United States

Location

CHU de Brest - Hôpital de la Cavale Blanche

Brest, Finistere, 29200, France

Location

Hopital Caremeau

Nîmes, Gard, 30029, France

Location

Groupe Hospitalier Pellegrin - Hôpital Pellegrin

Bordeaux, Gironde, 33076, France

Location

CHU Rennes - Hôpital Pontchaillou

Rennes, Ille Et Vilaine, 35033, France

Location

CHU Clermont Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, Puy De Dome, 63003, France

Location

CHU Amiens - Hopital Sud

Amiens, Somme, 80054, France

Location

Universitaetsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Neurologische Klinik Bad Neustadt/Saale

Bad Neustadt/Saale, Bavaria, 97616, Germany

Location

Universitaetsmedizin Goettingen

Göttingen, Lower Saxony, 37075, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

Kiel, Schleswig, 24105, Germany

Location

Rabin MC

Petah Tikva, Central District, 49100, Israel

Location

Health Corporation of Galilee Medical Center

Naharya, Northern District, 22100, Israel

Location

Chaim Sheba Medical Center

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Rambam Health Care Center

Haifa, 3109601, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Hadassah

Jerusalem, 9112001, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona

Torrette, Ancona, 60020, Italy

Location

ASST Monza - Ospedale San Gerardo di Monza

Monza Brianza, Milano, 20900, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Pama, Parma, 43126, Italy

Location

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

Milan, 20162, Italy

Location

Ospedale Maggiore di Novara

Novara, 28100, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00137, Italy

Location

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Kimitsu Chuo Hospital

Kisarazu-Shi, Chiba, 292-8535, Japan

Location

Kobe City Hospital Organization Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

Nara Medical University Hospital

Kashihara-shi, Nara, 634-8522, Japan

Location

Rinku General Medical Center

Izumisano, Osaka, 598-8577, Japan

Location

Nippon Medical School Hospital

Bunkyō City, Tokyo-to, 113-8603, Japan

Location

Yamaguchi University Hospital

Ube-Shi, Yamaguchi, 755-8505, Japan

Location

Hospital Universitari Son Espases

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, La Coruna, 15706, Spain

Location

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, 36312, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Brain Contusion

Interventions

Glyburide

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Contusions; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Limitations and Caveats

Early termination of trial due to strategic considerations, not for efficacy or safety reasons.

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: Biogen

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  Remedy Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 17, 2019
• Study Start: October 6, 2019
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: November 27, 2024
• Results First Posted: December 20, 2023

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (8); IT (7); FR (6); IL (7); JP (6); DE (4); US (25)