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AbbVie EAISE


Title A Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Study to Assess the Safety and Efficacy of Elezanumab in Acute Ischemic Stroke
Therapeutic Area Stroke
Principal Investigator Deborah Green-LaRoche, MD
Min Age 30 Years
Max Age 80 Years
Gender All
Contact Emma Jost-Price
617-636-7606
neuroresearch@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04309474

Overview

The purpose of this study is to see if the study drug, elezanumab, is safe and able to improve cognitive and/or motor functioning in an individual following the occurrence of acute ischemic stroke. This is a 52-week, Phase 2a, randomized, double-blind, parallel-group, placebo-controlled, multicenter proof-of concept study.

Study Details

Inclusion 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 initiate study drug administration within 24 hours of last known normal.
  • National Institute of Health Stroke Scale (NIHSS) total score of 7 to 21, inclusive.

Exclusion Criteria

  • The stroke is intended to be treated with endovascular therapy or symptoms are likely to resolve within a few hours.
  • Evidence of seizure at the onset of stroke.
  • Evidence of acute myocardial infarction (heart attack).

Study Requirements

The study procedures begin during your inpatient stay at Tufts Medical Center and then you are asked to come for 15 visits at the study site, after discharge from the hospital, over the period of about 1 year and 6 months.

After the last infusion of study drug (Week 48), you will come to the site 3 more times to see how you are doing since the intervention was stopped.

The study procedures include physical and neurological exams, taking of your vital signs (blood pressure, heart rate, and temperature), ECGs (a test which records the electrical activity of your heart), urine tests for illegally used drugs and alcohol abuse, CT Scan and MRIs (tests to make pictures of your brain), blood draws, and several assessments and scales.