New drug hopes to boost brain recovery after stroke
NCT ID NCT04309474
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This Phase 2 trial tested an experimental drug called elezanumab in 121 people who had an acute ischemic stroke. The goal was to see if it could safely improve neurological function and reduce disability compared to a placebo. Participants received the drug or placebo by IV within 24 hours of the stroke and then every 4 weeks for nearly a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- elezanumab (also called ABT-555)
- What this could lead to
- If it works, this could point toward a new treatment to help people recover better after a stroke and reduce long-term disability.
- What could go wrong
- This is a small, early Phase 2 proof-of-concept study, so results may not confirm benefit. The drug is still experimental, and side effects are unknown.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
121 people
The number who actually took part.
- Started
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Nov 2020
- Finished
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Dec 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
30 to 90 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Clinical diagnosis of acute ischemic stroke, supported by acute brain computed tomography (CT) or magnetic resonance imaging (MRI) consistent with the clinical diagnosis. * Able to randomize within 24 hours of last known normal. * National Institute of Health Stroke Scale (NIHSS) total score of 7 to 21, inclusive. * Participants or their legally authorized representative confirms that prior to index stroke, no significant impairment in participant's ability to perform activities of daily living without assistance. Exclusion Criteria: * Evidence of severe stroke on imaging based on available acute imaging studies performed under the standard of care. * Evidence of acute seizure at the onset of index stroke without conclusive imaging of ischemic stroke. * Evidence of acute myocardial infarction. * Symptoms are considered likely to resolve within the subsequent few hours (e.g., transient ischemic attack \[TIA\]). * Known history prior to randomization of clinically significant medical conditions (other than current acute ischemic stroke) or any other reason, including any physical, psychological, or psychiatric condition that in the investigator's opinion would compromise the safety or interfere with the participant's participation in this study. * Known medical history of repeated episodes of complex migraine. Participants with history of complex migraine, but with imaging conclusively demonstrating an acute ischemic stroke are still allowed. * 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. * Known receipt of any investigational product within 30 days or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug. No current enrollment in another interventional clinical study, including pharmacologic and behavioral interventional studies.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor Scott & White Medical Center- Temple /ID# 225513
Temple, Texas, 76508-0001, United States
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Cleveland Clinic Main Campus /ID# 214635
Cleveland, Ohio, 44195, United States
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Columbia University Medical Center /ID# 215122
New York, New York, 10032-3729, United States
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Complejo Hospitalario Universitario A Coruña /ID# 230080
A Coruña, A Coruna, 15006, Spain
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Duplicate_CHA University Bundang Medical Center /ID# 233503
Seongnam-si, Gyeonggido, 13496, South Korea
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Duplicate_Mayo Clinic /ID# 217567
Jacksonville, Florida, 32224, United States
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Duplicate_Pusan National University Hospital /ID# 233769
Busan, Busan Gwang Yeogsi, 49241, South Korea
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Duplicate_Royal North Shore Hospital /ID# 239083
St Leonards, New South Wales, 2065, Australia
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Duplicate_University of Kentucky Chandler Medical Center /ID# 216394
Lexington, Kentucky, 40536, United States
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Fukuoka University Chikushi Hospital /ID# 240629
Chikushino-shi, Fukuoka, 818-8502, Japan
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Fukuoka Wajiro Hospital /ID# 239810
Fukuoka, Fukuoka, 811-0213, Japan
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Georgetown University Hospital /ID# 216481
Washington D.C., District of Columbia, 20007, United States
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Hackensack Univ Med Ctr /ID# 218200
Hackensack, New Jersey, 07601, United States
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Hamilton General Hospital /ID# 218970
Hamilton, Ontario, L8L 2X2, Canada
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Hospital Donostia /ID# 218034
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
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Hospital Universitario La Paz /ID# 216380
Madrid, 28046, Spain
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Hospital Universitario Vall de Hebron /ID# 217087
Barcelona, 08035, Spain
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Hospital Universitario Virgen Macarena /ID# 216382
Seville, 41009, Spain
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Hospital Universitario Virgen del Rocio /ID# 216339
Seville, 41013, Spain
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Lehigh Valley Health Network /ID# 242446
Allentown, Pennsylvania, 18103, United States
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Long Beach Medical Center /ID# 217210
Long Beach, California, 90808-1731, United States
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Mayo Clinic Arizona /ID# 214957
Phoenix, Arizona, 85054, United States
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Nagano Municipal Hospital /ID# 240622
Nagano, Nagano, 3818551, Japan
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National Hospital Organization Kagoshima Medical Center /ID# 240021
Kagoshima, Kagoshima-ken, 892-0853, Japan
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Northwestern University Feinberg School of Medicine /ID# 215047
Chicago, Illinois, 60611-2927, United States
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OSI Ezkerraldea-Enkarterri-Cruces /ID# 217529
Barakaldo, Vizcaya, 48903, Spain
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Samsung Medical Center /ID# 234241
Seoul, Seoul Teugbyeolsi, 06351, South Korea
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Seoul National University Hospital /ID# 233473
Seoul, Seoul Teugbyeolsi, 03080, South Korea
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St. Luke's Marion Bloch Neuroscience Institute /ID# 215028
Kansas City, Missouri, 64111-3220, United States
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The Ohio State University /ID# 215036
Columbus, Ohio, 43210, United States
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The Royal Melbourne Hospital /ID# 240178
Parkville, Victoria, 3050, Australia
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Thomas Jefferson University Hospital /ID# 215469
Philadelphia, Pennsylvania, 19107, United States
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Tufts Medical Center /ID# 215053
Boston, Massachusetts, 02111-1552, United States
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UH Cleveland Medical Center /ID# 215372
Cleveland, Ohio, 44106, United States
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University of Alberta Hospital /ID# 218370
Edmonton, Alberta, T6G 2B7, Canada
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University of Louisville Hospital /ID# 217569
Louisville, Kentucky, 40202, United States
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University of Mississippi Medical Center /ID# 217587
Jackson, Mississippi, 39216-4500, United States
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University of New Mexico School of Medicine /ID# 216827
Albuquerque, New Mexico, 87131-0001, United States
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University of Texas Health Science Center at Houston /ID# 215018
Houston, Texas, 77030-1501, United States
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University of Virginia /ID# 215757
Charlottesville, Virginia, 22908, United States
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Washington University-School of Medicine /ID# 214526
St Louis, Missouri, 63110, United States
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Yamaguchi Grand Medical Center /ID# 239892
Hohu-shi, Yamaguchi, 747-8511, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Can tiny neural exosomes help the brain heal after a severe stroke?
- Can a new antibody boost recovery after severe stroke?
- After stroke, a balloon or a stent? trial tests which rescue opens blocked brain arteries better