Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104

NCT ID: NCT03413319

Last Updated: 2019-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2019-11-20

Brief Summary

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The purpose of this study is to assess the long-term safety and tolerability of ABBV-8E12 in subjects with progressive supranuclear palsy (PSP).

Detailed Description

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Conditions

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Progressive Supranuclear Palsy (PSP)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABBV-8E12

ABBV-8E12 administered by intravenous (IV) infusion.

Group Type EXPERIMENTAL

ABBV-8E12

Intervention Type DRUG

Solution for infusion

Interventions

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ABBV-8E12

Solution for infusion

Intervention Type DRUG

Other Intervention Names

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Tilavonemab

Eligibility Criteria

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Inclusion Criteria

* Subject completed Study C2N-8E12-WW-104 (NCT02494024)
* Subject was not eligible to enroll in Study M15-562 (NCT02985879)

Exclusion Criteria

* Subject weighs less than 35 kg at screening
* Subject has any contraindication or inability to tolerate brain MRI
* Subject has any significant change in his/her medical condition that could interfere with the subject's participation in the study, could place the subject at increased risk, or could confound interpretation of study results
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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University of California, San /ID# 170113

La Jolla, California, United States

Site Status

Texas Health Physicians Group /ID# 170112

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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M16-948

Identifier Type: -

Identifier Source: org_study_id

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