What side effects are associated with this type of intervention?

Common treatments for acute ischemic stroke include thrombolytics like alteplase and endovascular thrombectomy. Thrombolytics can cause bleeding complications, including intracranial hemorrhage, while endovascular procedures may lead to vascular injury, infection, or contrast-induced nephropathy. In the context of investigational drugs like Elezanumab, side effects are monitored closely in clinical trials and may include infusion-related reactions, immune responses, and other unforeseen adverse events. It is essential for patients to discuss potential risks and benefits with their healthcare provider.

What prior FDA approvals exist?

Currently, the FDA has approved several treatments for acute ischemic stroke, primarily focusing on thrombolytic and mechanical interventions. The most well-known FDA-approved drug is tissue plasminogen activator (tPA), which helps dissolve blood clots if administered within a few hours of stroke onset. Mechanical thrombectomy is another approved treatment, involving the physical removal of the clot using specialized devices. While Elezanumab is an investigational drug aimed at improving neurologic function post-stroke, there are no specific FDA-approved drugs with a similar mechanism of action currently available.

What other types of research exist?

Promising novel alternatives to Elezanumab for stroke patients include: 1) Tenecteplase, a thrombolytic agent that has shown better outcomes compared to alteplase in some studies. 2) Endovascular thrombectomy, which is increasingly used for large vessel occlusions and has shown significant benefits in improving functional outcomes. 3) Neuroprotective agents like NA-1 (nerinetide), which are being investigated for their potential to reduce brain damage post-stroke. 4) Stem cell therapy, which is being explored for its regenerative potential in stroke recovery.

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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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 through week 52

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

0 / 3Eligibility criteria met

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.