search
Back to results

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
AbbVie
About
Eligibility
Locations
Outcomes
Full info

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

40 Years - undefined (Adult, Older Adult)Does not accept healthy volunteers

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 14, 2018
    Last Updated
    August 16, 2019
    Sponsor
    AbbVie
    search

    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
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    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

    We'll reach out to this number within 24 hrs