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Summary

Eligibility
for people ages 40–99
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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

Official Title

A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Progressive Supranuclear Palsy

Keywords

Progressive Supranuclear Palsy tauopathy PSP Steele-Richardson-Olszewski syndrome

Eligibility

You can join if…

Open to people ages 40–99

  • Male or female subject with age 40 years or greater at the time of signed consent.
  • Meets the criteria for possible or probable progressive supranuclear palsy(Steele-Richardson-Olszewski Syndrome).
  • Presence of PSP symptoms for less than 5 years.
  • Subject is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker).
  • Subject has an identified, reliable, study partner (e.g., caregiver, family member,social worker, or friend).

You CAN'T join if...

  • Subjects who weigh less than 44 kg (97 lbs) at screening.
  • MMSE score less than 15 at screening.
  • Any contraindication or inability to tolerate brain magnetic resonance imaging (MRI).
  • Subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period.
  • Evidence of any clinically significant neurological disorder other than PSP.
  • The subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to DSM-V or ICD-10 criteria.
  • Subject has had a significant illness or infection requiring medical intervention in the past 30 days.

Locations

  • University of Southern California /ID# 149773 not yet accepting patients
    Los Angeles, California, 90033, United States
  • UCLA /Id# 144896 accepting new patients
    Los Angeles, California, 90095, United States
  • Cleveland Clinic Lou Ruvo Center for Brain Health /ID# 148919 not yet accepting patients
    Las Vegas, Nevada, 89106, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02985879
Phase
Phase 2
Study Type
Interventional
Last Updated
April 1, 2017
I’m interested in this study!