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[M19-148] A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke

[M19-148] A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke

Otani Tetsuya

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Contact Patients and HCP

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Complete

Dec. 17, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-Clinical diagnosis of acute ischemic stroke in anterior circulation, supported by acute brain computed tomography (CT) or magnetic resonance imaging (MRI) consistent with the clinical diagnosis.
-Able to randomize within 23 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 seizure at the onset of index 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.

Both

Acute Ischemic Stroke

Drug: Elezanumab
Intravenous (IV) infusion
Other Name: ABT-555

Drug: Placebo
Intravenous (IV) infusion

National Institutes of Health Stroke Scale (NIHSS) Total Score During the Treatment Period

Responder Status based on Modified Rankin Scale (mRS)

+81-835-22-4411

Nov. 29, 2021

Yes

AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications. Supporting Information: Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR), Analytic Code Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered. Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link. URL: https://www.abbvieclinicaltrials.com/hcp/data-sharing/

United States/Canada/Spain/South Korea