A Safety and Efficacy Study of Intravenous (IV) Elezanumab Assessing Change in Neurologic Function in Adult Participants With Acute Ischemic Stroke (EAISE)
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|ClinicalTrials.gov Identifier: NCT04309474|
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : September 11, 2020
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 80 subjects will be enrolled in 30 sites worldwide.
Participants will receive 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 will 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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke||Drug: Elezanumab Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke|
|Actual Study Start Date :||June 30, 2020|
|Estimated Primary Completion Date :||November 16, 2021|
|Estimated Study Completion Date :||September 29, 2022|
Participants will receive elezanumab dose A
Intravenous (IV) infusion
Other Name: ABT-555
Placebo Comparator: Placebo
Participants will receive placebo for elezanumab
Intravenous (IV) infusion
- National Institutes of Health Stroke Scale (NIHSS) total score during the treatment period [ Time Frame: 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.
- Responder Status based on modified Rankin Scale (mRS) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309474
|Contact: ABBVIE CALL CENTERemail@example.com|
|Study Director:||AbbVie Inc.||AbbVie|