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

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

Completed

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Key information

Conditions

Progressive Supranuclear Palsy (PSP) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cranial Nerve Diseases Eye Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Ocular Motility Disorders Ophthalmoplegia Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Supranuclear Palsy, Progressive Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San /ID# 170113, La Jolla, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABBV-8E12

Drug

Solution for infusion

Other names: Tilavonemab

Primary outcomes

Adverse Events

Time frame: From first dose of study drug to 20 weeks after last dose of study drug (up to 2 years, 5 months)

Adverse events and serious adverse events will be monitored throughout the dosing period and for approximately 20 weeks after the last dose.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jan 29, 2018
Registry last updated: Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed