4006-776-356 出国就医服务电话

免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion

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

Study Description
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

Study Design
Layout table for study information
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 6, 2021
Estimated Study Completion Date : May 29, 2022
Arms and Interventions
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.

Outcome Measures
Primary Outcome Measures :
  1. Proportion of Participants With Contusion Expansion [ Time Frame: Between 12 hours to 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 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 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.
  • 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.
  • Polytrauma (intra-abdominal or orthopedic trauma) requiring operative/surgical management, if known. Minor fractures requiring splinting or reduction of dislocations are permitted, as are nonoperative intra-abdominal injuries or placement of noninvasive external fixation devices.
  • 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.

Contacts and Locations

Contacts
Layout table for location contacts
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com

Locations
Show Show 60 study locations
Sponsors and Collaborators
Biogen
Investigators
Layout table for investigator information
Study Director: Medical Director Biogen
Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date June 9, 2021
Actual Study Start Date  ICMJE October 6, 2019
Estimated Primary Completion Date December 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2020)
Proportion of Participants With Contusion Expansion [ Time Frame: Between 12 hours to 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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • 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.
  • 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).
  • 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.
  • Change from Baseline in Absolute Hematoma Volume at Hour 24 [ Time Frame: Baseline up to Day 1 (Hour 24) ]
  • Change from Baseline in Absolute Edema Volume at Hour 96 [ Time Frame: Baseline up to Day 4 (Hour 96) ]
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of BIIB093 in Participants With Brain Contusion
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Brain Contusion
Intervention  ICMJE
  • Drug: BIIB093
    Administered as specified in the treatment arm.
    Other Names:
    • Glibenclamide
    • CIRARA
    • RP 1127
  • Drug: Placebo
    Administered as specified in the treatment arm.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: BIIB093
  • 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.
    Intervention: Drug: BIIB093
  • 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.
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 29, 2022
Estimated Primary Completion Date December 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • 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.
  • Polytrauma (intra-abdominal or orthopedic trauma) requiring operative/surgical management, if known. Minor fractures requiring splinting or reduction of dislocations are permitted, as are nonoperative intra-abdominal injuries or placement of noninvasive external fixation devices.
  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: US Biogen Clinical Trial Center 866-633-4636 clinicaltrials@biogen.com
Contact: Global Biogen Clinical Trial Center clinicaltrials@biogen.com
Listed Location Countries  ICMJE France,   Germany,   Israel,   Italy,   Japan,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954041
Other Study ID Numbers  ICMJE 252BN201
2018-003858-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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: https://vivli.org/
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP