Safety and Efficacy of Elezanumab in Acute Ischemic Stroke

Phase 1

• Conditions: Acute Ischemic Stroke; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; MedDRA version: 21.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disorders

• Registration Number: EUCTR2019-003753-29-ES
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-15
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

-Subjects or their legally authorized representative must voluntarily provide informed consent prior to the initiation of any study-specific procedure in a form approved by an independent ethics committee (IEC)/institutional review board (IRB). In the absence of subject's ability to provide informed consent, informed consent must be given by a person who has the legal right to act on behalf of the subject in accordance with local laws.
-Adult male or female, 30 to 80 years of age, inclusive.
-Clinical diagnosis of acute ischemic stroke within 23 hours of last known normal, supported by acute brain computed tomography (CT) or MRI consistent with the clinical diagnosis.
-Evidence of infarct within anterior circulation based on either clinical assessment and/or acute imaging.
-NIHSS total score of 7 to 21, inclusive. NIHSS eligibility must be confirmed within 1 hour before randomization. For subjects treated with IV tPA, NIHSS must be confirmed = 1 hour after completion of IV tPA treatment.
-Subjects or their legally authorized representative confirms that prior to index stroke, no significant impairment in subject's ability to perform activities of daily living (e.g., dressing, eating, walking, bathing, toileting) without assistance. Subjects with a history of stroke more than 6 months prior to enrollment are allowed, if there was no residual neurologic deficit, and subject was able to function independently prior to index stroke (e.g., pre-morbid mRS of 0 or 1).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

-Evidence of severe stroke on imaging based on available acute imaging studies performed under the standard of care.
-The index acute ischemic stroke is intended to be treated with endovascular therapy (intra-arterial tPA and/or mechanical thrombectomy), i.e., subjects who will be treated with endovascular therapy are not eligible.
-Evidence of seizure at the onset of index stroke based on assessments conducted per standard of care.
-Evidence of acute myocardial infarction based on assessments based on assessments per standard of care (e.g., elevated troponin levels, abnormal ECG).
-Symptoms are considered likely to resolve within the subsequent few hours (e.g., transient ischemic attack [TIA]).
-Known medical history of repeated episodes of complex migraine (e.g., weakness, vision, difficulty speaking). Subjects with history of complex migraine, but with imaging conclusively demonstrating an acute ischemic stroke are still allowed.
-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 subject's participation in this study.
-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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified