A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP).

  • Interventional
  • Not Recruiting
  • NCT02985879
Eligibility Details Visit Clinicaltrials.gov

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

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

Gender
All

Age Group
40 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - 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).

        Exclusion Criteria:

         - 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.
  • Progressive Supranuclear Palsy (PSP)

At a Glance

National Government IDNCT02985879

IRB#IRB16-1780

Lead SponsorAbbVie

Lead PhysicianTao Xie

Collaborator(s)N/A

EligibilityAll
40 Years and up
Not Recruiting