Study to evaluate the use of the investigational drug BIIB093 versus placebo in patients with a large hemispheric infarction.

Phase 1

• Conditions: Cerebral edema following Large Hemispheric Infarction; MedDRA version: 20.0Level: LLTClassification code 10008107Term: Cerebral edemaSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2017-004854-41-ES
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-17
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 680

Inclusion Criteria

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

Exclusion Criteria

1.Participant is likely to have supportive care withdrawn on the first day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