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Monoclonal Antibodies

Elezanumab for Stroke (EAISE Trial)

Phase 2
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of acute ischemic stroke, supported by acute brain computed tomography (CT) or magnetic resonance imaging (MRI) consistent with the clinical diagnosis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 through week 52
Awards & highlights

EAISE Trial Summary

This trial is being conducted to see if elezanumab is safe and effective in treating acute ischemic stroke. The trial will enroll 120 participants who will be given either the drug or a placebo, and neither the participants nor the doctors will know who is receiving which. The study will last for 52 weeks.

Who is the study for?
This trial is for adults who've had a recent acute ischemic stroke, can start treatment within 24 hours of their last normal health status, and have a moderate level of stroke severity. It's not for those with severe strokes on imaging, heart attack symptoms, significant other medical conditions, or women who are pregnant/breastfeeding.Check my eligibility
What is being tested?
The study tests Elezanumab against a placebo in patients following an acute ischemic stroke. Participants won't know which they're receiving. They'll get the drug/placebo via IV within 24 hours after symptoms start and every four weeks for nearly a year.See study design
What are the potential side effects?
While specific side effects of Elezanumab aren't listed here, participants may experience reactions related to IV infusion and will be monitored through medical assessments, blood tests, and evaluation of any side effects.

EAISE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a stroke, confirmed by a brain scan.

EAISE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 through week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 through week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
National Institutes of Health Stroke Scale (NIHSS) Total Score During the Treatment Period
Secondary outcome measures
Responder Status based on Modified Rankin Scale (mRS)

EAISE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ElezanumabExperimental Treatment1 Intervention
Participants will receive elezanumab dose A
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo for elezanumab

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
971 Previous Clinical Trials
505,007 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
406 Previous Clinical Trials
148,896 Total Patients Enrolled

Media Library

Elezanumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04309474 — Phase 2
Stroke Research Study Groups: Elezanumab, Placebo
Stroke Clinical Trial 2023: Elezanumab Highlights & Side Effects. Trial Name: NCT04309474 — Phase 2
Elezanumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04309474 — Phase 2
~17 spots leftby Jan 2025
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