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

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ClinicalTrials.gov Identifier: NCT03954041
Recruitment Status : Recruiting
First Posted : May 17, 2019
Last Update Posted : October 23, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

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.


Condition or disease Intervention/treatment Phase
Brain Contusion Drug: BIIB093 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 6, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bruises

Arm Intervention/treatment
Experimental: BIIB093 3 mg
Participants will be administered BIIB093 3 mg/day as a bolus followed by rapid and slow intravenous (IV) infusions for 96 hours.
Drug: BIIB093
Administered as specified in the treatment arm.
Other Names:
  • Glibenclamide
  • CIRARA
  • RP 1127

Experimental: BIIB093 5 mg
Participants will be administered BIIB093 5 mg/day as a bolus followed by rapid and slow IV infusions for 96 hours.
Drug: BIIB093
Administered as specified in the treatment arm.
Other Names:
  • Glibenclamide
  • CIRARA
  • RP 1127

Placebo Comparator: Placebo 3 mg
Participants will be administered matching placebo to BIIB093 as a bolus followed by rapid and slow IV infusions for 96 hours.
Drug: Placebo
Administered as specified in the treatment arm.

Placebo Comparator: Placebo 5 mg
Participants will be administered matching placebo to BIIB093 as a bolus followed by rapid and slow IV infusions for 96 hours.
Drug: Placebo
Administered as specified in the treatment arm.




Primary Outcome Measures :
  1. Proportion of Participants With Contusion Expansion [ Time Frame: Within 96 hours of start of study treatment infusion ]
    Participants with contusion expansion will be determined by comparison of the baseline images and the 96-hour scan or the scan obtained prior to any neurosurgical intervention (NSx) or comfort measures only (CMO). NSx includes craniotomy and decompressive craniectomy (DC).


Secondary Outcome Measures :
  1. Proportion of Participants With Improvement in Glasgow Outcome Scale - Extended (GOS-E) [ Time Frame: Day 90 ]
    The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates participant status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery. The Extended GOS (GOS-E) provides more detailed categorization into eight categories by subdividing the categories of severe disability, moderate disability and good recovery into a lower and upper category.

  2. Proportion of Participants With Improvement in Modified Rankin Scale (mRS) [ Time Frame: Day 90 ]
    The mRS measures the degree of disability or dependence in the daily activities of participants who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6, ranging from perfect health without symptoms (0) to dead (6).

  3. Proportion of Participants Requiring Delayed Intubation [ Time Frame: Day 1 (Hour 24) to Day 4 (Hour 96) ]
    Delayed intubation is defined as participants requiring intubation (for neurologic deterioration only) at any time between 24 hours and 96 hours postinjury.

  4. Change from Baseline in Absolute Hematoma Volume at Hour 24 [ Time Frame: Baseline up to Day 1 (Hour 24) ]
  5. Change from Baseline in Absolute Edema Volume at Hour 96 [ Time Frame: Baseline up to Day 4 (Hour 96) ]
  6. Time to All-cause Death [ Time Frame: Baseline up to Day 90 ]
    The treatment effects on overall survival of participants, including neurological death, will be assessed.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 14 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.
  • Clinical signs of brainstem herniation, in the opinion of the Investigator.
  • NCCT or magnetic resonance imaging (MRI) evidence of penetrating brain injury.
  • 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.
  • Polytrauma (intra-abdominal or orthopedic trauma) requiring operative/surgical management, if known. Minor fractures requiring splinting or reduction of dislocations is permitted, as are nonoperative intra-abdominal injuries.
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03954041


Contacts
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Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

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Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT03954041     History of Changes
Other Study ID Numbers: 252BN201
2018-003858-24 ( EudraCT Number )
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: October 23, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/
URL: http://www.biogenclinicaldatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Contusion
Contusions
Wounds, Nonpenetrating
Wounds and Injuries
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System