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

JRCT ID: jRCT2061210064

Registered date:17/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute Ischemic Stroke
• Date of first enrollment: 10/06/2022
• Target sample size: 120
• Countries of recruitment: United States,Japan,Canada,Japan,Spain,Japan,South Korea,Japan
• Study type: Interventional

Intervention(s)

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

Drug: Placebo
Intravenous (IV) infusion

Outcome(s)

• Primary Outcome: National Institutes of Health Stroke Scale (NIHSS) Total Score During the Treatment Period
• Secondary Outcome: Responder Status based on Modified Rankin Scale (mRS)

Key inclusion & exclusion criteria

• Age minimum: >= 30age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

-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.

Exclude criteria

-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.

Related Information

• Primary Sponsor: Otani Tetsuya
• Secondary ID(s): NCT04309474