A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Drug: PlaceboDrug: Elezanumab
- Registration Number
- NCT04309474
- Lead Sponsor
- AbbVie
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 121
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive placebo for elezanumab Elezanumab Elezanumab Participants will receive elezanumab dose A
- Primary Outcome Measures
Name Time Method National Institutes of Health Stroke Scale (NIHSS) Total Score During the Treatment Period Week 0 through Week 52 The National Institutes of Health Stroke Scale (NIHSS) is a neurological examination used to quantitatively measure the severity of acute stroke by evaluating impact of cerebral infarction on level of consciousness, gaze, visual field, facial palsy, motor ability of arm and leg, limb ataxia, sensation, language, dysarthria, and extinction/inattention. Domains are scored on a scale of 0 to 2, 0 to 3, or 0 to 4, for a total range of 0 -42 points with higher scores indicating impairment.
- Secondary Outcome Measures
Name Time Method Responder Status based on Modified Rankin Scale (mRS) Week 0 through Week 52 The mRS is used to assess participant's disability and functional dependence. It is a 6-point scale ranging from 0 (no symptoms) to 5 (severe disability), with additional rating of 6 if the participant is deceased.
Trial Locations
- Locations (42)
The Ohio State University /ID# 215036
🇺🇸Columbus, Ohio, United States
Lehigh Valley Health Network /ID# 242446
🇺🇸Allentown, Pennsylvania, United States
Tufts Medical Center /ID# 215053
🇺🇸Boston, Massachusetts, United States
UH Cleveland Medical Center /ID# 215372
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Main Campus /ID# 214635
🇺🇸Cleveland, Ohio, United States
Mayo Clinic Arizona /ID# 214957
🇺🇸Phoenix, Arizona, United States
Georgetown University Hospital /ID# 216481
🇺🇸Washington, District of Columbia, United States
Mayo Clinic /ID# 217567
🇺🇸Jacksonville, Florida, United States
Long Beach Medical Center /ID# 217210
🇺🇸Long Beach, California, United States
Northwestern University Feinberg School of Medicine /ID# 215047
🇺🇸Chicago, Illinois, United States
University of Kentucky Chandler Medical Center /ID# 216394
🇺🇸Lexington, Kentucky, United States
University of Louisville /ID# 217569
🇺🇸Louisville, Kentucky, United States
University of Mississippi Medical Center /ID# 217587
🇺🇸Jackson, Mississippi, United States
Hackensack Univ Med Ctr /ID# 218200
🇺🇸Hackensack, New Jersey, United States
St. Luke's Marion Bloch Neuroscience Institute /ID# 215028
🇺🇸Kansas City, Missouri, United States
Washington University-School of Medicine /ID# 214526
🇺🇸Saint Louis, Missouri, United States
Columbia University Medical Center /ID# 215122
🇺🇸New York, New York, United States
University of New Mexico School of Medicine /ID# 216827
🇺🇸Albuquerque, New Mexico, United States
University of Texas Health Science Center at Houston /ID# 215018
🇺🇸Houston, Texas, United States
Royal North Shore Hospital /ID# 239083
🇦🇺St Leonards, New South Wales, Australia
Thomas Jefferson University /ID# 215469
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Scott & White Medical Center- Temple /ID# 225513
🇺🇸Temple, Texas, United States
Nagano Municipal Hospital /ID# 240622
🇯🇵Nagano-shi, Nagano, Japan
University of Virginia /ID# 215757
🇺🇸Charlottesville, Virginia, United States
University of Alberta Hospital - Division of Hematology /ID# 218370
🇨🇦Edmonton, Alberta, Canada
The Royal Melbourne Hospital /ID# 240178
🇦🇺Parkville, Victoria, Australia
HHSC Hamilton General Hospital - David Braley Cardiac, Vascular and Stroke Resea /ID# 218970
🇨🇦Hamilton, Ontario, Canada
National Hospital Organization Kagoshima Medical Center /ID# 240021
🇯🇵Kagoshima-shi, Kagoshima, Japan
Fukuoka Wajiro Hospital /ID# 239810
🇯🇵Fukuoka-shi, Fukuoka, Japan
Fukuoka University Chikushi Hospital /ID# 240629
🇯🇵Chikushino-shi, Fukuoka, Japan
Yamaguchi Grand Medical Center /ID# 239892
🇯🇵Hohu-shi, Yamaguchi, Japan
CHA University Bundang Medical Center /ID# 233503
🇰🇷Seongnam si, Gyeonggido, Korea, Republic of
Pusan National University Hospital /ID# 233769
🇰🇷Busan, Korea, Republic of
Seoul National University Hospital /ID# 233473
🇰🇷Seoul, Korea, Republic of
Hospital Donostia /ID# 218034
🇪🇸Donostia, Guipuzcoa, Spain
OSI Ezkerraldea-Enkarterri-Cruces /ID# 217529
🇪🇸Barakaldo, Vizcaya, Spain
Hospital Universitario A Coruna - CHUAC /ID# 230080
🇪🇸A Coruna, Spain
Hospital Universitario Vall d'Hebron /ID# 217087
🇪🇸Barcelona, Spain
Hospital Universitario Virgen del Rocio /ID# 216339
🇪🇸Sevilla, Spain
Hospital Universitario Virgen Macarena /ID# 216382
🇪🇸Sevilla, Spain
Samsung Medical Center /ID# 234241
🇰🇷Seoul, Korea, Republic of
Hospital Universitario La Paz /ID# 216380
🇪🇸Madrid, Spain