A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04309474
• Other study ID #: M19-148
• Secondary ID: 2019-003753-29
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 9, 2020
• Est. completion date: February 23, 2025

Study information

• Verified date: June 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 121
• Est. completion date: February 23, 2025
• Est. primary completion date: January 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Elezanumab
Intravenous (IV) infusion
• Placebo
Intravenous (IV) infusion

Locations

Country	Name	City	State
Australia	The Royal Melbourne Hospital /ID# 240178	Parkville	Victoria
Australia	Royal North Shore Hospital /ID# 239083	St Leonards	New South Wales
Canada	University of Alberta Hospital - Division of Hematology /ID# 218370	Edmonton	Alberta
Canada	HHSC Hamilton General Hospital - David Braley Cardiac, Vascular and Stroke Resea /ID# 218970	Hamilton	Ontario
Japan	Fukuoka University Chikushi Hospital /ID# 240629	Chikushino-shi	Fukuoka
Japan	Fukuoka Wajiro Hospital /ID# 239810	Fukuoka-shi	Fukuoka
Japan	Yamaguchi Grand Medical Center /ID# 239892	Hohu-shi	Yamaguchi
Japan	National Hospital Organization Kagoshima Medical Center /ID# 240021	Kagoshima-shi	Kagoshima
Japan	Nagano Municipal Hospital /ID# 240622	Nagano-shi	Nagano
Korea, Republic of	Pusan National University Hospital /ID# 233769	Busan
Korea, Republic of	CHA University Bundang Medical Center /ID# 233503	Seongnam si	Gyeonggido
Korea, Republic of	Samsung Medical Center /ID# 234241	Seoul
Korea, Republic of	Seoul National University Hospital /ID# 233473	Seoul
Spain	Hospital Universitario A Coruna - CHUAC /ID# 230080	A Coruna
Spain	OSI Ezkerraldea-Enkarterri-Cruces /ID# 217529	Barakaldo	Vizcaya
Spain	Hospital Universitario Vall d'Hebron /ID# 217087	Barcelona
Spain	Hospital Donostia /ID# 218034	Donostia	Guipuzcoa
Spain	Hospital Universitario La Paz /ID# 216380	Madrid
Spain	Hospital Universitario Virgen del Rocio /ID# 216339	Sevilla
Spain	Hospital Universitario Virgen Macarena /ID# 216382	Sevilla
United States	University of New Mexico School of Medicine /ID# 216827	Albuquerque	New Mexico
United States	Lehigh Valley Health Network /ID# 242446	Allentown	Pennsylvania
United States	Tufts Medical Center /ID# 215053	Boston	Massachusetts
United States	University of Virginia /ID# 215757	Charlottesville	Virginia
United States	Northwestern University Feinberg School of Medicine /ID# 215047	Chicago	Illinois
United States	Cleveland Clinic Main Campus /ID# 214635	Cleveland	Ohio
United States	UH Cleveland Medical Center /ID# 215372	Cleveland	Ohio
United States	The Ohio State University /ID# 215036	Columbus	Ohio
United States	Hackensack Univ Med Ctr /ID# 218200	Hackensack	New Jersey
United States	University of Texas Health Science Center at Houston /ID# 215018	Houston	Texas
United States	University of Mississippi Medical Center /ID# 217587	Jackson	Mississippi
United States	Mayo Clinic /ID# 217567	Jacksonville	Florida
United States	St. Luke's Marion Bloch Neuroscience Institute /ID# 215028	Kansas City	Missouri
United States	University of Kentucky Chandler Medical Center /ID# 216394	Lexington	Kentucky
United States	Long Beach Medical Center /ID# 217210	Long Beach	California
United States	University of Louisville /ID# 217569	Louisville	Kentucky
United States	Columbia University Medical Center /ID# 215122	New York	New York
United States	Thomas Jefferson University /ID# 215469	Philadelphia	Pennsylvania
United States	Mayo Clinic Arizona /ID# 214957	Phoenix	Arizona
United States	Washington University-School of Medicine /ID# 214526	Saint Louis	Missouri
United States	Baylor Scott & White Medical Center- Temple /ID# 225513	Temple	Texas
United States	Georgetown University Hospital /ID# 216481	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Japan,  Korea, Republic of,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	National Institutes of Health Stroke Scale (NIHSS) Total Score During the Treatment Period	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.	Week 0 through Week 52
Secondary	Responder Status based on Modified Rankin Scale (mRS)	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.	Week 0 through Week 52