Expanded Access to ABBV-8E12
Primary Purpose
Primary Tauopathy Corticobasal Degeneration Syndrome (CBD)
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
ABBV-8E12
Sponsored by
About this trial
This is an expanded access trial for Primary Tauopathy Corticobasal Degeneration Syndrome (CBD) focused on measuring Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme.
Eligibility Criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03744546
Brief Title
Expanded Access to ABBV-8E12
Official Title
Expanded Access to ABBV-8E12
Study Type
Expanded Access
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
No longer 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 ABBV-8E12 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. 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
Primary Tauopathy Corticobasal Degeneration Syndrome (CBD)
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)
ABBV-8E12
Intervention Description
Solution for infusion
10. Eligibility
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 ABBV-8E12
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