← Back to Search

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
Must not have
Female who is pregnant, breastfeeding, or considering becoming pregnant during the study or for within 39 weeks (5 half-lives) after the last dose of study drug
Evidence of acute seizure at the onset of index stroke without conclusive imaging of ischemic stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 through week 52

Summary

This trial is testing a new drug called elezanumab to help people recover from a stroke. The study includes people who have had a stroke caused by a blocked blood vessel. Elezanumab is given through an IV and aims to help the brain heal better. The trial will check if the drug is safe and effective.

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant, breastfeeding, nor planning to become pregnant soon.
Select...
I had a seizure when my stroke started, but scans didn't show a clot-caused stroke.

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

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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for acute ischemic stroke include thrombolytics, antiplatelet agents, and anticoagulants. Thrombolytics, such as tissue plasminogen activator (tPA), work by dissolving the blood clot that is obstructing blood flow to the brain, thereby restoring circulation and minimizing brain damage. Antiplatelet agents, like aspirin, prevent platelets from clumping together to form new clots, reducing the risk of subsequent strokes. Anticoagulants, such as warfarin, inhibit the coagulation cascade to prevent clot formation. These treatments are crucial for stroke patients as they aim to restore blood flow and prevent further clotting, thereby reducing the extent of brain injury and improving outcomes. Elezanumab, an investigational drug, is being studied for its potential to improve neurologic function post-stroke, possibly by mechanisms that involve neuroprotection or promoting neural repair, which could offer additional benefits beyond clot management.

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,031 Previous Clinical Trials
521,619 Total Patients Enrolled
1 Trials studying Stroke
ABBVIE INC.Study DirectorAbbVie
452 Previous Clinical Trials
162,105 Total Patients Enrolled
1 Trials studying Stroke

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
~24 spots leftby Dec 2025