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 |
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Brain Contusion | Drug: BIIB093 Drug: Placebo | Phase 2 |
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 |
Arm | Intervention/treatment |
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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.
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Drug: BIIB093
Administered as specified in the treatment arm.
Other Names:
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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.
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Drug: BIIB093
Administered as specified in the treatment arm.
Other Names:
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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.
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Drug: Placebo
Administered as specified in the treatment arm.
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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.
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Drug: Placebo
Administered as specified in the treatment arm.
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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Contact: US Biogen Clinical Trial Center | 866-633-4636 | clinicaltrials@biogen.com | |
Contact: Global Biogen Clinical Trial Center | clinicaltrials@biogen.com |
Study Director: | Medical Director | Biogen |
Tracking Information | |||||||||
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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 |
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).
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Original Primary Outcome Measures ICMJE |
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).
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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 |
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Condition ICMJE | Brain Contusion | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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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 ) |
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Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Biogen | ||||||||
Study Sponsor ICMJE | Biogen | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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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 |