A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
Public ClinicalTrials.gov record NCT04309474. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Stroke is one of the leading causes death and major functional disability worldwide. Treatment options for acute stroke are limited with many patients having residual neurologic impairment. The purpose of this study is to evaluate the safety and efficacy of elezanumab and assess change in neurologic function in participants following an acute ischemic stroke. Elezanumab is an investigational drug being developed for the treatment of acute ischemic stroke. This 52-week study is "double-blinded', which means that neither the participants nor the study doctors will know who will be given elezanumab and who will be given placebo (does not contain treatment drug). Participants will be assigned to one of two groups, called treatment arms. Participants in one arm will receive elezanumab and participants in the other arm will receive placebo. There is a 1 in 2 chance that participants will be assigned to placebo. Approximately 120 subjects will be enrolled in 45 sites worldwide. Participants will be randomized to elezanumab or placebo by intravenous (IV) infusion within 24 hours of "last known normal" (time when the participant was last known to be without signs and symptoms of the current stroke) and every 4 weeks thereafter for 48 weeks for a total of 13 doses. There may be a higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of elezanumab will be checked by medical assessments, blood tests, evaluation of side effects, and completion of questionnaires.
Study identification
- NCT ID
- NCT04309474
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 121 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 90 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 9, 2020 (Actual)
- Primary completion
- Apr 18, 2024 (Actual)
- Completion
- Dec 23, 2024 (Actual)
- Last update posted
- Dec 22, 2025
2020 – 2024
United States locations
- U.S. sites
- 22
- U.S. states
- 16
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona /ID# 214957 | Phoenix | Arizona | 85054 | — |
| Long Beach Medical Center /ID# 217210 | Long Beach | California | 90808-1731 | — |
| Georgetown University Hospital /ID# 216481 | Washington D.C. | District of Columbia | 20007 | — |
| Duplicate_Mayo Clinic /ID# 217567 | Jacksonville | Florida | 32224 | — |
| Northwestern University Feinberg School of Medicine /ID# 215047 | Chicago | Illinois | 60611-2927 | — |
| Duplicate_University of Kentucky Chandler Medical Center /ID# 216394 | Lexington | Kentucky | 40536 | — |
| University of Louisville Hospital /ID# 217569 | Louisville | Kentucky | 40202 | — |
| Tufts Medical Center /ID# 215053 | Boston | Massachusetts | 02111-1552 | — |
| University of Mississippi Medical Center /ID# 217587 | Jackson | Mississippi | 39216-4500 | — |
| St. Luke's Marion Bloch Neuroscience Institute /ID# 215028 | Kansas City | Missouri | 64111-3220 | — |
| Washington University-School of Medicine /ID# 214526 | St Louis | Missouri | 63110 | — |
| Hackensack Univ Med Ctr /ID# 218200 | Hackensack | New Jersey | 07601 | — |
| University of New Mexico School of Medicine /ID# 216827 | Albuquerque | New Mexico | 87131-0001 | — |
| Columbia University Medical Center /ID# 215122 | New York | New York | 10032-3729 | — |
| UH Cleveland Medical Center /ID# 215372 | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic Main Campus /ID# 214635 | Cleveland | Ohio | 44195 | — |
| The Ohio State University /ID# 215036 | Columbus | Ohio | 43210 | — |
| Lehigh Valley Health Network /ID# 242446 | Allentown | Pennsylvania | 18103 | — |
| Thomas Jefferson University Hospital /ID# 215469 | Philadelphia | Pennsylvania | 19107 | — |
| University of Texas Health Science Center at Houston /ID# 215018 | Houston | Texas | 77030-1501 | — |
| Baylor Scott & White Medical Center- Temple /ID# 225513 | Temple | Texas | 76508-0001 | — |
| University of Virginia /ID# 215757 | Charlottesville | Virginia | 22908 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04309474, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 22, 2025 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04309474 live on ClinicalTrials.gov.