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Monoclonal Antibodies

BIIB093 for Brain Bruise (ASTRAL Trial)

Phase 2
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (24 hours) up to day 4 (96 hours) post-injury
Awards & highlights

ASTRAL Trial Summary

This trial is testing a drug to see if it can reduce the size of a brain contusion (injury) and improve outcomes.

Eligible Conditions
  • Brain Bruise
  • Cortical Contusion

ASTRAL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (24 hours) up to day 4 (96 hours) post-injury
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (24 hours) up to day 4 (96 hours) post-injury for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 96 Hours as Measured by Brain Imaging
Secondary outcome measures
Change From Baseline in Absolute Edema Volume at 96 Hours
Change From Baseline in Absolute Hematoma Volume at 24 Hours
Change From Baseline in Mean Total Contusion Volume (Hematoma Plus Perihematomal Edema) at 24 Hours as Measured by Brain Imaging
+4 more

ASTRAL Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: BIIB093 5 mgExperimental Treatment1 Intervention
Participants will be administered BIIB093 5 mg/day as a IV bolus followed by rapid and slow IV infusions for 96 hours.
Group II: BIIB093 3 mgExperimental Treatment1 Intervention
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.
Group III: PlaceboPlacebo Group1 Intervention
Participants will be administered BIIB093 matching placebo as a IV bolus followed by rapid and slow IV infusions for 96 hours.

Find a Location

Who is running the clinical trial?

BiogenLead Sponsor
639 Previous Clinical Trials
467,230 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,777 Previous Clinical Trials
8,063,796 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has BIIB093 been assessed in other clinical experiments?

"BIIB093 was first tested in 2009 at the Texas Diabetes Institute. 18,375 clinical trials related to this treatment have been conducted since then, with 6 currently recruiting patients primarily from Marietta, Georgia."

Answered by AI

Are there any openings available for this trial?

"Affirmative. Clinicaltrials.gov displays that this research project, which was first made available on October 6th 2019, is recruiting participants at the current moment in time. 160 volunteers must be found from 16 distinct medical sites."

Answered by AI

Who meets the criteria to qualify for this experiment?

"This medical trial is currently recruiting 160 individuals with brain contusions ranging in age from 18 to 85. In order to be eligible, participants must possess a clinical diagnosis of brain contusion and show lesions on non-contrast computed tomography scans totalling more than 3 mL per the Investigator's assessment. Additionally, they must have a Glasgow Coma Scale score between 5 and 15 upon screening as well as display functional independence prior to sustaining their index head injury."

Answered by AI

Is this an unprecedented clinical test?

"BIIB093 has been trialled in 207 cities across 25 nations. This drug, backed by Amylin Pharmaceuticals LLC., was initially tested in 2009 with the participation of 521 individuals. Following its Phase 4 completion, 18375 additional studies have since concluded."

Answered by AI

Does the research study include elderly individuals in its sample population?

"As indicated by the requirements for this experiment, only those over 18 and below 85 are eligible to participate."

Answered by AI

How many locations are actively conducting this trial?

"This medical trial is being held in 16 different locations, including Marietta, Boston and Dallas. To reduce the strain of participation, it's best to select a clinic near you for enrollment."

Answered by AI

What is the participant recruitment level for this clinical investigation?

"To carry out this medical study, Biogen requires 160 eligible patients spread between the Research Facility in Marietta, Georgia and Research Site in Boston, Massachusetts."

Answered by AI

Has BIIB093 received authorization from the FDA?

"Our experts at Power have judged the safety of BIIB093 to be a 2 out of 3, as this is only in its Phase 2 clinical trial; while there is some evidence backing up its safety there still needs to be data collected proving efficacy."

Answered by AI
~17 spots leftby Apr 2025