BIIB093 for Brain Edema

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Brain Edema+4 More
BIIB093 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether a drug called BIIB093 improves functional outcome for people with Large Hemispheric Infarction (LHI) compared to placebo. The trial has two parts. The first part is to determine if the drug improves functional outcome at Day 90 and overall survival at Day 90. The second part is to evaluate long-term disability following LHI, to evaluate long-term outcome measures of clinical function, quality of life, and healthcare utilization, and to assess the safety of BIIB093 in subjects with LHI during the follow-up period.

Eligible Conditions
  • Brain Edema
  • Stroke, Acute

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Brain Edema

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Month 6 and 12

Hour 72
Part 1: Reduction in Midline Shift at 72 Hours
Day 90
Part 1: Number of Participants Who Achieved mRS 0-4 at Day 90
Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Part 1: Percentage of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS)
Part 1: Time to All-Cause Death
Month 12
Part 2: HealthCare Resource Utilization (HCRU) Questionnaire: Number of Participants With Visits to Healthcare Professionals for Treatment
Part 2: Zarit Burden Interview Score
Month 6 and 12
Part 2: Barthel Index (BI) Score
Part 2: EuroQol 5-Level Assessment of Health Outcomes (EQ-5D-5L) Score
Cerebrovascular accident
Part 2: mRS Score
Up to Month 12
Part 2: Number of Participants With SAEs

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Brain Edema

Trial Design

2 Treatment Groups

BIIB093
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

768 Total Participants · 2 Treatment Groups

Primary Treatment: BIIB093 · Has Placebo Group · Phase 3

BIIB093
Drug
Experimental Group · 1 Intervention: BIIB093 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 6 and 12

Who is running the clinical trial?

BiogenLead Sponsor
553 Previous Clinical Trials
442,748 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,618 Previous Clinical Trials
7,936,057 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory.
The study drug infusion must be initiated no later than 10 hours after symptom onset, if known, or the time last known normal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: October 20th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
65+100.0%
What site did they apply to?
Research Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%