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
This is further along than 85% of similar trials
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
This is further along than 85% of similar trials
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: DrugPlacebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial 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 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 York | 100.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| Research Site | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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