Back to resultsExpanded Access to Elezanumab
Primary Purpose
Acute Spinal Cord Injury (SCI), Acute Ischemic Stroke
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Elezanumab
Sponsored by
About this trial
This is an expanded access trial for Acute Spinal Cord Injury (SCI) focused on measuring Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Eligibility Criteria
Inclusion Criteria:
- The participant must not be eligible for an elezanumab clinical trial.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04278235
Brief Title
Expanded Access to Elezanumab
Official Title
Expanded Access to Elezanumab
Study Type
Expanded Access
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
5. Study Description
Brief Summary
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Elezanumab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Spinal Cord Injury (SCI), Acute Ischemic Stroke
Keywords
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Elezanumab
Other Intervention Name(s)
ABT-555
Intervention Description
Solution for intravenous (IV) infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- The participant must not be eligible for an elezanumab clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Expanded Access to Elezanumab
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