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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
954 Previous Clinical Trials
500,984 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
394 Previous Clinical Trials
145,818 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are in the sample size for this clinical trial?

"In order for this clinical trial to be completed, 120 eligible patients must agree to participate. These potential participants can hail from different locations, such as Washington D.C.'s Georgetown University Hospital (ID# 216481) or Long Beach Medical Center in California (ID#217210)."

Answered by AI

What are some other notable examples of research that has been done with Elezanumab?

"There are currently 2 clinical trials studying Elezanumab with 0 in Phase 3. The majority of these research studies are based in Montreal, but there are 92 sites total across the world conducting these investigations."

Answered by AI

Is this clinical trial being conducted in multiple hospitals within the city?

"Georgetown University Hospital in Washington D.C., Long Beach Medical Center in California, Hackensack Univ Med Ctr in New Jersy are a few of the 24 locations where this trial is being conducted."

Answered by AI

Are there any vacancies in this experiment for new participants?

"That is correct. The listing on clinicaltrials.gov indicates that the trial administrators are still looking to enroll patients. This particular study was first posted on November 9th, 2020 and was last updated on August 15th, 2022. They aim to have 120 individuals participate from 24 different sites total."

Answered by AI

Has there been any prior research conducted on this topic?

"Currently, there are 2 ongoing trials for Elezanumab in 58 cities and 7 nations. The first trial took place in 2020 and was completed successfully at the Phase 2 drug approval stage. In total, 18294 clinical trials have been conducted since 2020."

Answered by AI

Who does this research include in its participants?

"This study is looking for 120 individuals aged 30-90 who have had a cerebrovascular accident. Other important requirements are that patients must be able to randomize within 24 hours of their last known normal, and they or their legal representative must confirm that prior to the index stroke, the participant was not significantly impaired in their ability to perform activities of daily living without assistance. The diagnosis of acute ischemic stroke must be supported by brain CT or MRI consistent with the clinical diagnosis, and the NIHSS total score must be between 7 and 21 inclusive."

Answered by AI

What is the current stage of Elezanumab's FDA approval process?

"Elezanumab's safety is estimated to be a 2. This is Phase 2, so while there are some data supporting its safety, there are no such studies for efficacy."

Answered by AI

Could you please clarify the age requirements for this particular experiment?

"This trial is for patients aged between 30-90, which falls in the middle range of age groups with clinical trials. In total, 78 other trials exist for patients under 18 and 1307 for those over 65."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
University of Texas Health Science Center at Houston /ID# 215018
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
2020. "A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04309474.
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