Status:
COMPLETED
A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
Lead Sponsor:
AbbVie
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
30-90 years
Phase:
PHASE2
Brief Summary
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 purpos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2024
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT04309474
Start Date
November 9 2020
End Date
December 23 2024
Last Update
December 22 2025
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic Arizona /ID# 214957
Phoenix, Arizona, United States, 85054
2
Long Beach Medical Center /ID# 217210
Long Beach, California, United States, 90808-1731
3
Georgetown University Hospital /ID# 216481
Washington D.C., District of Columbia, United States, 20007
4
Duplicate_Mayo Clinic /ID# 217567
Jacksonville, Florida, United States, 32224