Study to evaluate the use of the investigational drug BIIB093 versus placebo in patients with a large hemispheric infarction.
- Conditions
- Cerebral edema following Large Hemispheric InfarctionMedDRA version: 20.0Level: LLTClassification code 10008107Term: Cerebral edemaSystem Organ Class: 100000004852Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2017-004854-41-IT
- Lead Sponsor
- BIOGEN IDEC RESEARCH LIMITED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 535
1.A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory
2.A large hemispheric infarction defined as; lesion volume of 80 to 300 centimeters cubed (cm^3) on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI), or computed tomography perfusion (CTP), or an Alberta Stroke Program Early CT Score (ASPECTS) of 1 to 5 with involvement of at least 2 defined cortical regions
3. Screening National Institutes of Health Stroke Scale (NIHSS) >=10
4. Study treatment infusion within 10 hours after time of symptom onset, if known, or the time last known normal
5. For participants who receive thrombectomy, inclusion into the study must be based on post-thrombectomy MRI-DWI
NOTE: Other protocol defined Inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 102
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 578
1.Participant is likely to have supportive care withdrawn on the first day
2.Commitment to decompressive craniectomy (DC) prior to enrollment
3.Evidence of concurrent infarction in the contralateral hemisphere sufficiently serious so as to affect functional outcome
NOTE: Other protocol defined Exclusion criteria may apply
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine if BIIB093 improves functional outcome at Day 90 as measured by the modified Rankin Scale (mRS) when compared with placebo in participants with Large Hemispheric Infarction (LHI).;Secondary Objective: The secondary objectives are to determine if BIIB093 improves overall survival at Day 90 when compared with placebo, if BIIB093 improves functional outcome at Day 90 on the mRS dichotomized 0-4 vs. 5-6 when compared with placebo, if BIIB093 reduces midline shift at 72 hours (or at time of decompressive craniectomy [DC] or comfort measures only [CMO], if earlier) when compared with placebo, and to evaluate the safety and tolerability of BIIB093 in participants with LHI. ;Primary end point(s): <br>Proportion of Participants with Improvement in Functional Outcome at Day 90 Assessed via the Modified Rankin Scale (mRS);Timepoint(s) of evaluation of this end point: Baseline up to Day 90
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.Time to All-Cause Death [ Time Frame: Baseline up to Day 90 ] 2.Proportion of Participants who achieved mRS 0-4 at Day 90 [Time Frame: Baseline up to Day 90] 3.Reduction in Midline Shift at 72 Hours [ Time Frame: Baseline up to 72 Hours] 4.Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 90];Timepoint(s) of evaluation of this end point: #’s 1, 2 & 4 (Baseline up to Day 90) #3 (Baseline up to 72 hours)